Quality Assurance Department

Main responsibilities:

To perform planned and systematic actions to ensure that the company products meet the quality required for their intended use. Thus Quality Assurance principles are to ensure that:

• GMP and other regulatory codes are respected.
• All testing, controls, calibrations, validations, etc. are performed as specified.
• Products are appropriately handled throughout their shelf-life.
• There is a procedure for self-inspections and audits.

The QA Departments can be structured in four units:

• Documentation
• Inspection and Audit
• Validation
• Batch Release

These units will have the following functions:

Documentation:

1. To establish the policy and general procedures for the documents management through its life cycle.
2. To organize and control the documents management, which includes the regulatory documentation as well as the documentation for recording purposes, supporting or related to the Company Quality System.

Inspection and Audit:

1. To organize and perform GMP and GLP inspections, to check GMP and GLP compliance in the Production areas and QC Laboratories respectively.
2. To organize and perform (or supervise) the quality inspections, to determine if a product or material meets its specifications. It includes incoming, in-process and final quality inspections.
3. To organize and perform the follow-up of corrective and preventive actions derived from audits and inspections.
4. To perform inspections to the finished products before its delivery or shipment.
5. To perform inspections to the destruction of rejected products or materials.

  Validation:

1. To establish the general procedures for performing the validation actions.
2. To coordinate the validation and qualification actions in the processes and facilities.
3. To organize and control the documentation derived from the validation actions.
4. To elaborate the environmental monitoring program for the established areas and supervise its performance, coordinating the participation of the related areas in the results’ analysis and follow-up of the required actions.
5. To organize and manage the changes control system for the production processes and analytical assays.

Batch Release:

1. To perform the review of the documentation that support the history of each batch of Active Pharmaceutical Ingredient and finished product, including the batch production record, analytical testing, inspection results, deviations, environmental monitoring, among other documents, to check the conformance with the approved specifications.
2. To prepare the documentation supporting the release or rejection of each batch of Active Pharmaceutical Ingredient and finished product, for its approval by the authorized person.
3. To prepare the quality certificates for the finished products that have been released, according to the requirements of the National Drug Regulatory Authority.