While all Performance Standards are applicable to this investment, IFC’s environmental and social due diligence indicates that the investment will have impacts which must be managed in a manner consistent with the following Performance Standards:
PS1: Social and Environmental Assessment and Management Systems
PS2: Labor and Working Conditions
PS3: Pollution Prevention and Abatement; and
PS4: Community Health, Safety and Security
PS5 (Land Acquisition and Involuntary Resettlement) is not applicable because the land acquisition for the existing facilities has not resulted in any involuntary physical relocation and/or economic displacement. Similarly, for the expansion projects, land acquisition resulting in involuntary displacement as envisaged by PS5 is not expected. However, with regards to future greenfield developments, if any, the company will develop policies and procedures to comply with PS5 requirements, in case any of these developments encounter involuntary resettlement or economic displacement as summarized under PS1 section.
Since none of the company operations is located in or within the area of influence of environmental sensitive areas, PS 6 (Biodiversity Conservation and Sustainable Management of Living Natural Resources) is not applicable. Furthermore,PS7 (Indigenous Peoples) is not relevant to this project because of the absence of Indigenous People in the area of influence of the company’s operations. Regarding PS8 (Cultural Heritage), although no cultural resources have been identified the company will prepare a “chance find” procedure to be applied in the event of any accidental unearthing of paleontological/cultural relics during future greenfield developments.
If IFC’s investment proceeds, IFC will periodically review the project’s ongoing compliance with the Performance Standards.

This is a category B project according to IFC’s Policy on Environmental and Social Sustainability because the Environmental, Social and Health & Safety (ESHS) impacts related to the investment are limited, site specific, covers a footprint of existing brownfield assets, and the associated E&S impacts can be managed through the implementation of appropriate mitigation measures. IFC’s review did not identify any significant adverse impacts or high-risk exposures.
Key E&S risks and issues for this project are typical of those for pharmaceutical production and distribution. These include: adequate development and implementation of a comprehensive EHS and social management system; labor standards, worker rights, and implementation of occupational health and safety (OHS) measures; adequate management of air pollution/hazardous materials/ hazardous waste/wastewater; project’s impacts on the community health, safety and security and the use of armed security.

IFC’s appraisal considered the environmental and social management planning process and documentation for the Project and gaps, if any, between these and IFC’s requirements. Where necessary, corrective measures, intended to close these gaps within a reasonable period of time, are summarized in the paragraphs that follow and (if applicable) in an agreed Environmental and Social Action Plan (ESAP). Through implementation of these measures, the Project is expected to be designed and operated in accordance with Performance Standards objectives.

Environmental and Social Assessment and Management System
The company has established a corporate EHS management system and organizational structure to oversee the E&S performance of its operations. All facilities have a documented EHS management system manual consisting of an EHS policy and site level standard operating procedures (SOPs) for the identification and management of E&S and OHS risks and impacts; emergency preparedness and response; and monitoring and reporting of EHS performance to the corresponding regulatory authorities.
As required by the local environmental authorities, all operations conduct environmental assessments, as needed, to identify risks and determine appropriate mitigations and demonstrate compliance with host country requirements.
For the development of new facilities, as per the local regulatory requirements and in accordance with IFC requirements, Procaps shall engage external consultants to conduct needed Environmental and Social Impact Assessments (ESIA) and develop environmental management plans (EMP) covering both the construction and operation phases.

Assessing and Complying with Performance Standard Requirements for Future Developments
IFC’s investment may be used in the future for developing facilities yet to be designed and constructed. Locations / land for these developments are yet to be identified and finalized. The company shall, therefore, assess all new business opportunities (including potential acquisitions) against, and comply with, the requirements of IFC PSs.
For this purpose, the company will develop and SOP as part of its ESMS, which will include the Scope of Work for the ESIA studies for all the future greenfield developments, including an assessment of applicability of the IFC PSs. In case, issues related to these PSs are encountered, Procaps will develop necessary mitigation measures to ensure compliance with the applicable requirements of the PSs (see action #1 of the ESAP.)
Similarly, for the acquisition of any existing facility, the company will commission E&S specialists to conduct due diligence audits including vis-à-vis the requirements of IFC PSs and develop corrective action plans and implementation timetables to ensure compliance with the applicable IFC PS requirements in a time bound manner.
Moreover, in compliance with this SOP, the company will commission an E&S assessment for the proposed integration and relocation of its operations in El Salvador (see action # 2 of the ESAP.)

Management Programs
Procaps’ flagship facility in Barranquilla is certified compliant with the requirements of ISO 14000:2004 and BASC (Business Alliance for Secure Commerce) and operates its plants in accordance with the current good manufacturing practices (“GMP”) and high-quality standards. GMP is a system for ensuring that products are consistently produced and controlled according to quality standards; it covers all aspects of production, from the raw materials, premises and equipment to the training and personal hygiene of staff.
In line with the GMP requirements, he company has detailed written procedures for this facility to ensure high quality of the finished product with documented evidence confirming that the GMP procedures are consistently followed at each step in the manufacturing process - every time a product is made. Several aspects of EHS are also covered under the requirements of GMP. Moreover, this is the first Latin American pharmaceutical production facility to receive approval from US Food and Drugs Administration (US FDA) to manufacture and export prescription (Rx) drugs to the U.S. This facility also has approvals from European, Japanese, and Russian regulators.
Both Pharmayect and Alinova are GMP certified and have implemented their corresponding environmental management systems (EMS). Pharmayect is preparing to apply for ISO 14001 certification in 2017. As Alinova produces products for general consumption, it has the food safety management system certification based on hazard and critical control point (HACCP) analysis. In addition, this operation is also Halal (certified by the international Muslim community) and Pfizer Laboratories certified. Pfizer is one of Procaps’ biggest clients, operates in highly regulated markets and under very strict and world-class international standards.
Laboratorios Lopez, Biokemical, and Softcaps are GMP certified facilities. In addition, Biokemical complies with US FDA requirements for all products distributed in the US. As part of the EMS, all operations have EHS monitoring and reporting programs in place, which include monitoring of the parameters required by the local requirements as well as those of GMP. As part of the project, Procaps operations will complement as needed the parameters to be monitored to demonstrate they will be operating in accordance with the applicable requirements of the WBG EHS Guidelines for Pharmaceutical and Biotechnology Manufacturing.
It was evident during the visit, that the current EHS systems and procedures developed by the company are being implemented on the ground, and in general are aligned with good international industry practices (GIIP.)

Organizational Capacity and Competency
At the corporate level, the company has appointed dedicated EHS personnel. This team is led by the Maintenance and Environmental Management Director, who is supported by Energy / Water / Fuels and Residues Management managers, and an EMS coordinator. It also has a Health and Safety (H&S) manager, who is supported by the H&S committee comprising of management and workers’ representatives, that reports to the Director of Human Capital. At corporate level, the company also has adedicated HR team consisting of one director and three supporting specialists; while each facility has its own HR teams, structured according to the number of employees.
At operations level, even though the general managers are ultimately responsible for the EHS aspects at their respective operation, adequate EHS organizational structures are established at each facility to manage the day-to-day EHS activities.
Pharmayect and Alinova in Bogota report directly to Procaps; Laboratorios Lopez, Biokemical, and Softcaps run independently but are aligned with Procaps’ corporate policies and values. All the operations conduct EHS trainings including at induction, periodic in-depth training, as well as special training for identified risky activities. The training programs forms part of the broader EHS management systems as well as GMPs.

Emergency Preparedness and Response
All operations have emergency response and contingency plans in place which are based on identified hazards and risks. In general, the sites have evacuation plans/routes and designated and clearly marked assembly points; they have dedicated fire and emergency response brigades; and maintain fire prevention as well as firefighting equipment including smoke detectors, alarm systems, fire extinguishers, fire hydrant systems with dedicated fire water storage and sprinklers.
Each facility also conducts periodic firefighting trainings and fire drills. Pharmayect participates in the common emergency response program established in the industrial park where it is located and conducts joint emergency drills with others in the estate, in addition to those it conducts internally. So far, none of the company operations have had any accident or significant emergencies. As part of this project, the company will upgrade the emergency response plans for the Procaps operations in Barranquilla and the Pharmayect operations in Bogota; and it will also update the emergency response plans for those facilities with expansion plans. (see action # 3 of the ESAP.)

Human Resources Policies and Procedures
The company’s corporate HR policy and procedures are rooted in the values that guide their actions with staff, partners and suppliers, customers and the communities and environments in which they operate. The company promotes transparent application of its labor policy through its code of conduct and a series of measures including broadly communicating the company’s policies on equal opportunity, local hiring practices and grievance mechanisms. The company has a zero-tolerance policy for discrimination or harassment and has qualified HR personnel at all its operations. The company’s HR policy is aligned with the labor laws of the countries where it operates and with IFC PS2.

Working Conditions and Terms of Employment
The terms of employment, which are defined in the internal employment rules and regulations, are provided to each employee upon hiring. They include benefits, hours of work and overtime compensation, life insurance, health insurance, pension plan, etc. The company gives fringe benefits to its employees, such as transportation aid and bonus payments based on performance, among others. All these employment benefits and other details are included in each employee’s individual file, which contains the written contract, remuneration details, company policies and the relevant procedures, all signed at the time of recruitment.
All operations promote local hiring. The total number of employees for all operations is approximately 3,900. Female employees constitute approximately 54% of the total workforce. Most of the company’s direct and contracted employees are located in Barranquilla, Colombia, where the company has its headquarters and core manufacturing facilities.

• In Barranquilla, there are 2.159 employees, of which 1,986 are direct and 173 are indirect employees; out of the total, 68% are female.
• Pharmayect has 248 employees, of which 228 are direct and 20 are indirect employees; out of the total, 65% are female.
• Alinova has 153 employees (141 direct and 12 indirect); of which, 82% are female and the majority are heads-of-household.
• Laboratorios Lopez has 625 employees (621 direct and 4 indirect); out of the total, 65% are women.
• Biokemical has 130 employees (125 direct and 5 indirect); of which 66% are female .In addition, Biokemical has hired 25 disabled persons to work at its operations.
• Softcaps has 268 employees (238 direct and 30 indirect); out of the total, 55% are female.
• The company also has commercial activities in Ecuador (90 employees), Peru (116 employees), and Bolivia (59 employees).

The company has a pro-active policy, as demonstrated by the numbers, to hire female employees. The working hours at the company operations are as follows: Procaps Barranquilla, and Bogota operations run three 8 hours shifts, seven days a week; Softcaps in Brazil run three 7-hour shifts, 6 days a week, and the operations in El Salvador run two 8 hour shifts, five days a w eek. The company uses extra hours, depending on production needs and fully complies with local law requirements related to overtime benefits.

Workers’ Organization
The company’s HR policy establishes freedom of association for all the employees. Rymco in Colombia has workers organized in registered unions. In Brazil, the company complies with all the directives set by the sector labor unions even though it has no workers affiliated to the unions. None of the remaining operations have workers affiliated to labor unions. All operations have maintained overall good relationships and friendly labor climate and up-to-date there have not been any labor conflicts in the company’s operations.
Non-discrimination and Equal Opportunity
The company’s HR policy also includes provisions related to non-discrimination based on race, nationality, disability, social class, sex, religion and/or political ideas. The company is an equal opportunity employer that extends equal employment opportunity to all applicants and its selection decisions are merit based.
The minimum hiring age in the countries where Procaps have operations is 18 years old, thus in compliance with the local law and IFC PS2, the project’s own as well as contracted personnel are all older than 18 years. In addition, in compliance with the local requirements as well as IFC PS 2 there is no forced labor in either its or contracted operations. No evidence of such was found during the site visits by IFC.
Retrenchment
The company does not expect any retrenchment due to the proposed project. However, if such becomes necessary in future, the company will develop and implement a retrenchment plan based on consultations with the affected workers, unions, the national labor requirements, and in accordance with IFC’s PS2 requirements.
Grievance Mechanism
All the company operations, with the exception of the Biokemical operations in El Salvador, have labor grievance mechanisms in place consistent with the IFC PS 2 requirements. The grievance mechanisms define communication channels, including the option of submitting grievances by mail, phone, in person, as well as anonymously. At all plants, the grievance mechanism is an integral part of the human resources policy and it is communicated to all own and contracted employees. For purposes of the project, the company will maintain a database with information regarding grievances, results of which will be reported quarterly to senior management. The company will activate a grievance mechanism for the Biokemical operations in El Salvador, that it has recently developed and it is in the implementation process.
Occupational Health and Safety (OHS)
Each of the company operations has its own OHS manual, which also overlaps with some of the GMP requirements (i. e., evaluating work-related risks, preventing occupational impacts, maintaining records of accidents and incidents, and implementing corrective measures to reduce negative OHS impacts, etc.) All operations have safety procedures in particular for high risk activities (i.e., hormone manufacturing) and conduct periodic safety inspections. As part of its operations and in accordance with GMP the operations have (i) installed steam vents and pressure release valves directed away from worker’s access areas; (ii) partitioned workplace areas with good dilution ventilation and/or differential air pressures; and (iii) ventilation hoods or isolation devices where toxic materials are handled. In addition, the manufacturing areas have heating ventilation and air conditioning (HVAC) systems in place, which include high efficiency particulate air (HEPA) filters in the ventilation systems, particularly in sterile product manufacturing areas; and local exhaust ventilation (LEV) with flanged inlets to capture fugitive dusts and vapors released at open transfer points. Specifically, for the Brazil plant, as part of its standard operation procedures, it has established specific air circulation frequencies as well as the percentages of primary, secondary, and as needed tertiary filtration. As part of the project, the company will provide details of the HEPA filters ventilation performance and filtration types and efficiencies for the remaining of the operations and confirm that those are in accordance to GPM (see action # 4 of the ESAP.) The local authorities have awarded several of the operations for health and safety good practices.
As part of the OHS management system, the operations develop yearly health and safety action plans for its operations and distribution centers. As part of the OHS manuals, each operation has its corresponding operational safety procedures. As Procaps and Pharmayect will be expanding their operations as part of this proposed project, these operations will upgrade their corresponding operational safety procedures, particularly in Laboratorios Lopez due to the betalactamics production (see action # 5 of the ESAP.) As part of managing the working conditions, all operations track and monitor accidents and incidents. Hand injuries appear as the most prevalent accident type. To further assess the potential likelihood and severity of the exposure of the workers to current hazardous conditions and those resulting from the proposed project, the company is committed to conduct job risk assessments for all its operations (see action # 6 of the ESAP) as well as to conduct workplace monitoring at all its operations to establish the working conditions baseline and to assess the effectiveness of its safety measures (see action # 7 of the ESAP.) Furthermore, as the company has just begun an ergonomic assessment of the workers’ conditions at all sites and as part of the project, it will complete the assessment and implement the resulting recommendations.
The operations have appropriate medical services and conduct medical check-ups, targeted for those employees working in high risk areas (i.e., biomechanical risks, exposure to noise, hormones, etc.) and provide adequate personnel protective equipment (i.e., uniforms, respiratory protective devices, safety shoes, etc.) as per specific potential risks, which are required to be used at all times. In general, the sites visited exhibited well-maintained production areas, good housekeeping and safety management practices.

Resource Efficiency
The company aims for continuous improvement in its energy consumption and accordingly, each plant undertakes energy reduction initiatives. Procaps flagship facility in Barranquilla has a detailed strategy to optimize the use of energy and water and to reduce the generation of residues. The company is currently starting an energy optimization program for its highconsumption systems and equipment (viz. heating, ventilation and air-conditioning or HVACs), and as part of this project, it will develop and implement an energy consumption monitoring system. Pharmayect has installed, LED lamps and motion sensors as well as a closed loop cooling system; thereby reducing its cooling water consumption to zero. Laboratorios Lopez is currently considering converting the manufacturing of its solid products from wet to dry process. As part of this project, the company will further define and begin implementing energy optimization measures at all its operations (see action # 8 of the ESAP.)
Energy and Material Efficiency Projects
All facilities procure their needed electricity from the national grid. Procaps Barranquilla generates about 78% of its electricity requirements through a natural gas combustion engine onsite; while the remaining 22% is procured from the national grid. Procaps flagship facility in Barranquilla, Pharmayect in Bogotá and Softcaps in Brazil all have diesel-powered generators as back-up to be used occasionally in case of power failure. Laboratorios Lopez has a small diesel-powered generator as back-up in the raw materials warehouse.
Water and Wastewater
The water needs for all its operations are met from the municipal water supply systems. For the processes, the operations have necessary water treatment systems in place.
Currently, Procaps flagship facility in Barranquilla treats its wastewater along with those generated by Naturmega in a single wastewater treatment plant (WWTP.) The treated effluents, which are currently discharged to the municipal system, are in compliance with the local requirements. but not with the WBG Environmental, Health, and Safety Guidelines for Pharmaceuticals and Biotechnology Manufacturing (Table.2.) As part of this project, the company will segregate the wastewaters from both Procaps and Naturmega operations and build separate WWTPs for both plants. It is anticipated that Procaps treated wastewater will comply with the IFC requirements.
Rymco discharges its domestic liquid effluents to the municipal system. The process wastewater is currently collected by an authorized local service provider who treats them prior discharge into the municipal system. As part of this project, the company will install a wastewater treatment facility (see actions 9.1 and 9.2 in the ESAP.)
Pharmayect’ s wastewater is discharged to the municipal system. The effluent concentrations comply with both, local and IFC requirements. Alinova does not release liquid effluents off premises, an authorized company collects them and uses them for irrigation of green areas.
In El Salvador, Laboratorios Lopez segregates its process and domestic wastewaters. The domestic effluents are released to the municipal sewage system and the process wastes, once treated in the onsite WWTP, are also released to the municipal system. The treated effluents comply with the local requirements. As part of this project, this operation will upgrade, as needed, its WWTP to ensure the treated effluents will be in accordance to the IFC requirements (see action 9.3 of the ESAP.) Biokemical does not require a water treatment system because as a conditioning laboratory, it does not manufacture medicine. Softcaps in Brazil has a WWTP to treat both domestic and process wastes. Once treated, they are discharged into the municipal system. The discharged effluents comply with the local requirements. As part of this project, this operation will upgrade, as needed, its WWTP to ensure the treated effluents will be in accordance to the IFC requirements (see action 9.4 of the ESAP.)
The sludge generated at the WWTPs is collected and handled as a hazardous waste by licensed contractor as per the environmental permit condition.
GHG Emissions
Except for the operations in Barranquilla that source 22% from the natural grid, the remaining facilities procure their needed electricity from the national grid. Diesel generators are present at sites as back up to be used in case of power failure. GHG emissions generation is thus dominated by electricity consumption. Other sources considered when calculating the GHG emissions are natural gas, LPG gas combustion, and diesel combustion. The GHG fuel combustion emissions from the Procaps operations reached 3,000 tCO2 equivalent and those from electricity use reached 9,000 tCO2equivalent in 2015. The project is not expected to produce GHG emissions in exceedance of IFC’s threshold of 25,000 tons per annum of CO2e.
Air Emissions and Ambient Air Quality
Procaps in Barranquilla and Pharmayect in Bogota, both have each two natural gas boilers. and each consumes a total of 540,000 m3 and 380,000 m3 of natural gas per year, respectively. Alinova has a natural gas fired boiler which will be replaced by a new high capacity and high efficiency natural gas boiler in 2017 which will consume 280,000 m3 of natural gas per year. The existing boiler will be kept as a backup. Laboratorios Lopez has a propane gas boiler, which will consume 29.48MT of propane per year. Softgel in Brazil has a fuel boiler which will consume 281 MT of GLP per year.
All operations control the fugitives and particulate emissions from their production areas, especially powders handling areas, and powders transfer points - through high efficiency particulate air filters. Specifically, Procaps’ flagship facility in Barranquilla has seven release points to the atmosphere equipped with dust collection equipment and determine these emissions via mass balance. These are reported to be in compliance with local and the WBG Environmental, Health, and Safety Guidelines for Pharmaceuticals and Biotechnology Manufacturing (Table.1.) The collected material and the filters are collected and sent for final treatment as part of the hazardous wastes of the entire operation. In addition, Laboratorios Lopez, has installed dust collectors and vapor extractors and has improved the workplace air quality in the impressions and liquid packaging areas.
Noise
Currently, Procaps’ flagship facility is the only operation that monitors and reports workplace noise monitoring results. It samples five different points. In general, the noise levels are in compliance with the applicable WBG EHS Guidelines and local regulatory requirements with the exception of one. Procaps is implementing noise reduction measures at these noise sources. Laboratorios Lopez also has recently installed noise reduction controls at noise sources (i.e., compressors.) As per ESAP action #7 the company will conduct noise monitoring at all the remaining operations as part of workplace monitoring as described earlier.
Solid Waste Management
All operations have adequate systems and procedures in place to handle their solid and hazardous wastes. GMP are used for handling of hazardous waste at all facilities. The plants have adequate hazardous waste areas to segregate (i.e., pharmaceutical, microbiological, off-spec product, etc.,) store, and dispose hazardous wastes. Specifically, Procaps sends the hazardous residues to be incinerated, it periodically audits the disposal site, and checks on the incinerator’s air emissions compliance. In addition, the residues from the Alinova consumption processing areas are melted and used as pigs feed or to soil conditioning.
All operations contract licensed waste handling companies for the transport and disposal of both hazardous and non-hazardous solid waste and maintain registries of the transportation of the disposal wastes to the final destinations to ensure proper disposal. Paper, plastic, uncontaminated solvents, scrap steel and other metal wastes are stored on site until a sufficient volume is accumulated and then sold for reuse.
Hazardous Materials
Raw materials or active pharmaceutical ingredients used in the manufacturing process are specialty materials, sourced from highly specialized and reputed manufacturers – many of whom comply with GMP requirements. All operations keep a list of hazardous materials used in production, which are handled and stored according to respective material safety data sheets and GMP requirements. These clearly identify and segregate active and non-active raw material, are kept in locked storerooms under negative pressure, with adequate dust collectors, constant air exchange, and thus overall maintain good organization and housekeeping. As needed, the storerooms have impermeable floor to avoid soil contamination from spills; as needed, the secondary containment for spill control. The stores are located away from the manufacturing areas in accordance with good industry practice. In addition, all chemical dosing points are properly designed to contain any spill.
Pesticide Use and Management
The use of pesticides in relatively low and it is used to manage pests and plagues in the operations with warm climate. Management of pesticides and agrochemicals follows best practice procedures.

Hazardous Materials Management and Safety
Transportation of raw materials and products at all operations is contracted. The operations have well-established transportation management programs addressing the needed safety measures for vehicles transporting hazardous materials operating on-or off-site companies’ premises. For instance, they work with certified transportation companies, establish contracts enforcing safety practices, have check-up protocols and checklists and rigorously conduct inspections for trucks coming and going out, for long distances they require trucks having GPS installed; etc.
To further enhance its practices, Laboratorios Lopez will conduct an audit of the transportation and final disposal of its hazardous wastes (see action # 10 of the ESAP.)
For the transfer of raw materials and products from Barranquilla to Bogota, the company relies on air transportation and the logistical and road transportation in Bogota is being contracted to DHL. So far, all operations have registered zero transportation related incidents/accidents.
Emergency Preparedness and Response
The company has emergency and contingency plans for situations such as spills, fire, explosion, medical evacuation, etc. as indicated. As part of this project, Procaps in Barranquilla will conduct its first emergency drill with participation of nearby communities (see action #11 of the ESAP.).
Security Personnel
Procaps in Barranquilla contracts armed security services. The security personnel receive training related to legal aspects, use of arms, and respect to communities. In addition, there are two police stations nearby its operations. Pharmayect and Alinova have non-armed contracted security services. Operations in El Salvador hires armed security forces. In Brazil, security is supplied by the industrial park where the plant is located.
The company will commit to run its operations in line with the Voluntary Principles on Security and Human Rights, and shall conduct a security risk assessment as per the requirements of PS4 to ascertain the risks posed by its security arrangements to those within and outside its facilities and to determine whether such private security personnel are being hired, equipped, and trained adequately in light of PS4, including on human rights issues, proper use of force, and appropriate conduct toward workers, and other stakeholders. In addition, the company will develop a clear policy and appropriate procedures and guidelines for how to manage its armed guard force to avoid potential harm to, employees, contractors, communities and other stakeholders. (see action # 12 of the ESAP.)

The company has established a foundation “Fundación Procaps”, that is in charge of implementing social programs in the nearby communities of the Procaps operations in Barranquilla. It has in place a community grievance mechanism allying with the requirements of IFC PS 1. Most complaints relate to the needs they have (i.e., employment, jobs, etc.) As part of its outreach, the company hires personnel from the local communities, maintains a health brigade, has a group of approximately 350 employees working as volunteers in various programs within the community. Laboratorios Lopez has a program of reforestation; specifically, in 2015, it planted trees in the premises.

Documents to be disclosed are:
- Environmental and Social Review Summary (ESRS)
- Environmental and Social Action Plan (ESAP)
The complete set of documentation is available locally at the following locations:
Contact Person: Eduardo Herrera
Company Name: Procaps S.A.
Disclosure Address: Calle 80 # 78B – 201
Email: eherrera@procapsgroup.com
Phone: 5753719253
City: Barranquilla
Country: Colombia

Contact Person: Mauricio Castañeda
Company Name: Procaps S.A.
Disclosure Address: Calle 80 # 78B – 201
Email: mcastaneda@procapsgroup.com
Phone: 5753719301

Contact Person: Eduardo Herrera
Company Name: Alinova
Disclosure Address: Av. Boyacá 23 – 66
Email: eherrera@procapsgroup.com
Phone: 5753719253
City: Bogota
Country: Colombia

Contact Person: Eduardo Herrera
Company Name: Pharmayect
Disclosure Address: Cra. 129 # 22b – 57, Bogotá
Email: eherrera@procapsgroup.com
Phone: 5753719253
City: Bogotá
Country: Colombia

Contact Person: Eduardo Herrera
Company Name: Laboratorios Lopez
Disclosure Address: Boulevard del Ejército Nacional, Km. 5 1/2, apartado postal 285
Email: eherrera@procapsgroup.com
Phone: 5753719253
City: San Salvador
Country: El Salvador

Contact Person: Eduardo Herrera
Company Name: Biokemical
Disclosure Address: Kilómetro 17 1/2 Calle Alberto Masferrer 174-A Barrio Las Mercedes Santo Tomas
Email: eherrera@procapsgroup.com
Phone: 5753719253
City: San Salvador
Country: El Salvador

Contact Person: Eduardo Herrera
Company Name: Softcaps
Disclosure Address: Estrada dos Estudantes, 349, Cotia, 06707-050
Email: eherrera@procapsgroup.com
Phone: 5753719253
City: Sao Paulo
Country: Brazil

Broad Community Support is not applicable for this project

Carnelian(39029) Supervision Disclosure Snapshot – Version 2
Description	Anticipated Completion Date	Status	Comments	Completion Date
Assessment of E&S Risks and Impacts 1. As part of the ESMS, the company will develop a Standard Operating Procedure (SOP) which will include (a) a corporate land acquisition and ESIA procedure to screen all the potential new developments and acquisitions,	30-Nov-2017	Completed	Completed	6/30/2018
2. In compliance with the SOP developed under #1 above, the company will commission an E&S assessment (impacts/mitigations) for the proposed merging integration and relocation of its operations in El Salvador	30-Nov-2017	Completed	Completed	6/30/2018
Emergency Response Plans 3. Update the Emergency Response Plan for: (a) Procaps operations in Barranquilla due to the expansion of the Softgel plant (b) Pharmayect operations in Bogota due to the capacity doubling of the softcaps operations (c) Operations with expansion programs	31-Oct-2017	Completed	Completed	4/13/2018
Workplace Conditions 4. For each of the operations, (a) Procaps and Rymco in Barranquilla (b) Pharmayect and Alinova in Bogota, (c) Laboratorios Lopez and Biochemical in San Salvador, and (d) Softcaps in Brazil, • provide details about the percentages of air recirculation through the HEPA filters into the preparation rooms, • indicate whether the remaining air, if any, is vented to the outside or whether all air is HEPA filtered; • indicate whether the contaminated ducts are under positive or negative pressure; • indicate whether the cabinets are equipped with a continuous monitoring device to allow confirmation of adequate air flow and cabinet performance	31-Dec-2018	Completed	Completed	1/15/2019
Process Safety Procedures 5. Update the Safety Procedures for: (a) the Procaps operations in Barranquilla due to the expansion of the plant	31-Oct-2017	Completed	Completed	6/30/2018
(b) Update the Process Safety Procedures for the Pharmayect operations in Bogota due to the capacity doubling of the softcaps operations to be completed in July 2017	30-Dec-2017	Completed	Completed	6/30/2018
Job Risk Assessments 6. Submit a copy of the job risk assessment for (a) each of the operations (i) Procaps and Rymco in Barranquilla, (ii) Pharmayect and Alinova in Bogota, (iii) Biokemical in San Salvador, and (iv) Softcaps in Brazil (b) the new activities resulting for the expansion of the operations of the Procaps operations in Barranquilla (c) Implement resulting recommendations	30-Nov-2017	Completed	Completed	6/30/2018
Workplace Monitoring 7. Conduct and submit baseline workplace monitoring (dust, vapors, noise, etc.) for (i) Procaps and Rymco operations in Barranquilla (ii) Pharmayect and Alinova operations in Bogota, (iii) Laboratorios Lopez and Biokemical in San Salvador, and (iv) Softcaps in Brazil	31-Dec-2017	Completed	Completed	6/30/2018
Energy Optimization 8. Implement energy optimization programs (1) Develop and implement an energy consumption monitoring system and begin implementing energy optimization measures for the Procaps operations in Barranquilla	31-Oct-2017	Completed	Completed	6/30/2018
2) Submit copy of the energy optimization actions (a) in place and (b) to be implemented along with implementation timetable for (i) Rymco in Barranquilla; (ii) Pharmayect and Alinova in Bogota, (iii) Laboratorios Lopez and Biochemicals in San Salvador, and (iv) Softcaps in Brazil	31-Dec-2017	Completed	Completed	6/30/2018
Wastewater Treatment 9. Wastewater Treatment Plants: (1) Install wastewater treatment plants for the Barranquilla Procaps operations (2) Install wastewater treatment plants for the Rymco operations	30-Jun-2018	Completed	Completed	1/15/2019
(3) Upgrade the wastewater treatment plant of Laboratorios Lopez to ensure compliance with IFC requirements and conduct monitoring of treated wastewater to ascertain compliance (4) Upgrade the wastewater treatment plant of Softcaps in Brazil to ensure compliance with IFC requirements and conduct monitoring of treated wastewater to ascertain compliance	31-Dec-2018	Completed	Completed	1/15/2019
Transportation 10. Conduct an audit of the transportation and final disposal of the hazardous materials generated at the Laboratorios Lopez	31-Oct-2017	Completed	Completed	6/30/2018
Emergency Response 11. Conduct the first emergency response drill, including the nearby communities, at the Procaps plant in Barranquilla (a) Protocol of the emergency response drill	30-Nov-2017	Completed	Completed	12/15/2017
(b) Evidence and recommendations resulting from the drill	31-Dec-2017	Completed	Completed	12/15/2017
Security Management 12. The company will commit to run its operations in line with the Voluntary Principles on Security and Human Rights, and shall conduct a security risk assessment as per the requirements of PS4 as described in ESRS and update / develop as appropriate the Security Management Plan for each: (i) Procaps and Rymco in Barranquilla (ii) Pharmayect and Alinova in Bogota	31-Oct-2017	Completed	Completed	12/15/2017
12. The company will commit to run its operations in line with the Voluntary Principles on Security and Human Rights, and shall conduct a security risk assessment as per the requirements of PS4 as described in ESRS and update / develop as appropriate the Security Management Plan for each:iii) Laboratorios Lopez and Biokemical in San Salvador, and (iv) Softcaps in Brazil in Barranquilla; as per IFC PS 4 requirements	31-Dec-2017	Completed	Completed	12/15/2017