Quality Assurance (QA) is a Key department in the Pharmaceutical industry, by monitors, controls, and maintains Product Quality.
Quality Assurance (QA) in Pharma Industry
To achieve the right quality product, quality should be built into every stage of the process. Consistency of quality requires the implementation of systems and procedures, adequate training, compliance, and continuous improvements based on audits and incident investigations (but not limited to).
Stay tuned here for never before “Quality Assurance Vs Quality Control (QA vs QC)” article
Quality Control (QC) in Pharmaceutical industry
Refer to Essential Pharma Interview Questions and Answers 2023 for Quality Assurance Interview Questions
Refer to Indojobs for Pharma Jobs (Quality Control / Quality Assurance)
Role of Quality Assurance (QA) department
QA department role assumes a high level of importance in building quality at all stages.
- Designing the right quality (the method shall validate per guidelines).
- Defining and documenting the systems and procedures (translating the method into STP, spec and moa, and ROA without errors).
- Ensuring compliance to laid down systems (analyst shall be trained & certified, performs as per the Spec & MoA, and records online).
- Continuous improvements (OOS/ OOT/ Incident records, Investigations, and systems improvement).
In view of the critical nature of medicines, in the pharma context, the regulations call for checking and ensuring compliance by a team independent of manufacturing. While guidelines accept QC checking (testing) since it is independent of manufacturing, most companies also have a QA officer to oversee the compliance even in QC. This arrangement is done with a belief that a QA officer with expertise in QC will be able to provide better assurance in the QC at all the above 4 stages.
Responsibility for Quality Assurance (QA)
The Quality Assurance department shall be responsible to formulate systems for the implementation of cGMP in various departments in accordance with the requirements outlined in 21 CFR 210 and 211 and the EC guide to GMPs with the roles, responsibilities, and authority as defined below.
QA Review procedure
Review and approve all written procedures and changes thereto, that impact production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Review and approve all specifications, standards, sampling plans, test procedures, or other laboratory-control mechanisms required, including any changes in specifications, standards, sampling plans, test procedures, or other laboratory-control mechanisms.
Release or reject the product upon review of all aspects relating to manufacturing, packaging, and control of the final product. Ensure that all materials meet standards and specifications prior to release.
Review and reconcile final product labeling and assure that labeling documentation shall include in the batch history records.
Ensure that each batch or lot of raw material and components are identified properly. If the results meet specifications, perform record keeping, review data, and provide final disposition for the following:
- Raw Materials
- Primary Packaging Components
- Printing and Labeling Materials
- Finished Products.
QMS (Training, Investigations, and CAPA)
Assure that all laboratory’s Out-of-Specification (OOS) is investigated, tracked, and approved.
Provide assurance that an effective CAPA program is implemented and verify the effectiveness of implemented CAPAs at an appropriate frequency.
Provide assurance that training programs are adequate, properly administered, and documented for all personnel involved in the production, control, holding, or distribution of all pharmaceutical products and components.
Retention Sample Management
Maintain a program for retaining samples of raw materials and final product for potential retesting. Coordinate the appropriate selection, storage, and examination of reserve samples from all commercial product lots.
Have the authority to control all documentation systems that impact product quality, manufacturing control, and validation. Maintain an archive of executed batch production records and release records for components and raw materials in accordance with the company retention policies and the applicable cGMP regulations.
Assure that adequate programs exist and are followed for validation (process, analytical, cleaning, and computers) as well as documentation systems.
Stability Management
Monitor management of stability samples for commercial production, product development, and contract manufacturing.
Approve stability protocols and confirm adherence to SOPs relating to stability programs and alert reported stability failures to site & central QA management.
Stability shall monitor according to a continuous ongoing stability program that will permit the detection of any stability issue (e.g. changes in levels of impurities or dissolution profile) associated with the formulation in the marketed package.
Prepare stability compilation reports for inclusion with annual product reviews, and annual updates to regulatory filings for new and/or existing products.
Ensuring that the results of ongoing stability studies shall be made available to key personnel and in particular, to qualified persons.
The quality Assurance department shall be responsible to ensure the availability of method validations for sterility and BET.
Comprehensive Quality Review System
The QA review system shall be adequate to enhance increased surveillance of completed activities and their related documentation with respect to the Manufacturing, Packing, Holding, and Distribution of drug products.
These checklists shall aid in understanding the prerequisites of certain activities that shall complete as per the designed flow and sequence of activities. For example, while reviewing an equipment qualification report, QA shall verify whether the equipment manufacturer recommendations are available in regular procedures. This also allows the reviewer to verify whether the summary and conclusions of validation reports are effective for regular operating instructions.
Some of the GMP-related documents pertaining to the Manufacturing, Packing, Holding, and Distribution of drug products that are reviewed by QA upon completion are listed here but are not limited to:
- Product development report.
- Method development/validation/site transfer product.
- Master production records/packing records/Executed batch records.
- Process validation records/Reports.
- Sampling plan protocols/Reports.
- Stability protocols/Reports.
- Specifications, Standard testing procedures, General testing procedures
- Microbiological review (MLT, Bioburden, BET, Sterility, EMP, Container closure integrity test, other related validation in microbiology)
- URS, FDS, IQ, OQ, and PQ protocols/Reports for all manufacturing/Utility equipment.
- SMF
- VMP/CSVMP/CVMP
- Validation matrix (includes revalidation)
- PMP checklist/schedules for equipment and instruments.
- Calibration procedures/schedules
- Layouts and document master list
- SOPs, STPs, OIs of all production, QC, Utilities, and warehouse.
- Change controls.
- Investigations (Incidents, Deviations, OOS and OOT, etc)
- CAPA review.
- Training review.
- All equipment /utility usage, cleaning, and maintenance logs.
Periodic Review of the Quality Management System
Once a month, QA shall review the log books and records of all the departments for compliance with respect to completeness, adequacy, and correctness. The review shall acknowledge by signature.
If any documentation errors are identified during the review, the same shall be trended and necessary training shall be imparted to relevant personnel.
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