Quality Assurance (QA) in EDCL plays a crucial role in ensuring that pharmaceutical products are manufactured, tested, and released in compliance with regulatory requirements and quality standards. Quality Assurance (QA) and its Quality Control (QC) laboratory in EDCL ensure the safety, efficacy, and quality of drugs and medical products before they reach patients. Here’s a brief description for a personnel who will find information about our Quality Assurance Department:

1. Equipment and Instruments:

• Analytical Instruments: The basic instruments are: High Performance Liquid Chromatography (HPLC), Gas   Chromatography (GC), Atomic Absorption Spectrophotometer (AAS), Spectrophotometers, Dissolution     Testers,Infrared spectrometers (FTIR) for analyzing drug substances and formulations, etc.
• Microbiological Instruments: Incubators, autoclaves, laminar flow hoods, and microbial enumeration systems for     testing microbial contamination and sterility.

2. Testing Areas:

• Chemical Testing: Various chemical testing are performed like analysis of raw materials, packaging materials,     intermediates and finished products to ensure they meet pharmacopeial standards for purity, identity, strength,     and composition.
• Microbiological Testing: Examination for microbial contamination, sterility testing, and endotoxin testing to      ensure products are free from harmful microorganisms.
• Stability Testing:  Long-term and accelerated stability studies to provide evidence on how the quality of a drug     substance or drug product varies with time under the influence of a variety of environmental factors such as     temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the     drug.

3. Quality Control (QC) Processes:

• Sampling and Testing: Sampling protocols are followed to ensure representative samples are tested accurately.     Testing includes assay, dissolution, disintegration, content uniformity, hardness, and friability tests, etc.
• Validation and Calibration: Validation of analytical methods and calibration of instruments are carried out to    ensure reliability and accuracy of test results. Process validation of various dosage forms to ensure the consistent    production of quality products. Cleaning validation to ensure contamination free safe and potent drugs products.
• Data Integrity:  Strict adherence to data integrity principles (ALCOA) to ensure all testing data is accurate,     complete, and attributable.

4. Compliance and Documentation:

• Regulatory Compliance: Adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and    regulatory guidelines set by national regulatory agency DGDA and sometime where required other national     regulatory bodies.
• Documentation:  Comprehensive record-keeping of all testing procedures, results, and other data as per Good     Documentation Practice.
• Data Integrity:  Strict adherence to data integrity principles (ALCOA) to ensure all testing data is accurate,     complete, and attributable.
  • Change Control Management: Any change to facilities, utilities, equipment, formulations, components,     manufacturing processes, specifications, analytical methods or documentation used in the manufacture     or testing of a product are assessed for its impact on product quality and regulatory compliance prior    to implementation. Changes are justified by adequate data, including product stability and process     validation data where appropriate. The whole procedure is maintained as per respective SOP.
  • Deviation Management: All deviations from SOPs, specifications or processing instruction or any other    events that may affect the quality are recorded in the details at the time of event.
  • CAPA Management:  For implementing the recommendations raised from the scope of any deviations in    the quality system (areas i.e, SOP, BMR, Market complaints, Internal Audit, Planned modifications, Change    control etc.) CAPA is taken and closed within the stipulated time line. The process of CAPA is followed    as per SOP.
  • Quality Risk Management(QRM):  is carried out for change control , planned deviation, confirmed OOS,    invalidated OOS , substantiated market complaints, product recall situation and for the other quality    issues where necessary such as process optimization, process validation, equipment qualification, new    product manufacturing , cleaning validation, new equipment introduction etc. Appropriate tools like “    Risk ranking and filtering” or Failure Mode and effect analysis is used as appropriate to ensure a    comprehensive risk assessment to identify potential risk on product quality, efficacy and patient safety as    well as to formulate risk mitigation action plan.

5. Personnel and Training:

• Qualified Personnel: Sampling protocols are followed to ensure representative samples are tested accurately.     Testing includes assay, dissolution, disintegration, content uniformity, hardness, and friability tests, etc.
• Continuous Training: Ongoing training programs are performed to keep staff updated on new regulations,     technologies, and best practices. Training needs are identified on the basis of nature of work, work performance,     knowledge and frequency of job perform. This assessment conducted by Departmental heads as per SOP.

   

  Training Coordinator prepares annual training calendar based on training needs. These training programs are periodically updated. In addition, during training emphasis is laid on regulatory requirement/updates, health, hygiene and safety.

  Training involves in-house and sometimes outside factory premises where training is conducted by external trainer. All employees are provided with training in confirmatory with their needs. Some common trainings are as follow:

  • GxP Training (x refers to Manufacturing, Laboratory, Engineering, Were house, documentation, etc.)
  • On the job training on critical process
  • Good laboratory practices(GPL) Training
  • Class Room Training on Routine Process (day to day)
  • External Training
  • Safety Training

6. Quality Assurance Oversight:

• QA Audits and Self-Inspections: Regular audits of laboratory operations and procedures are carried out to ensure    compliance with internal protocols and regulatory requirements. The purpose of self-inspection is to evaluate    the manufacturer’s compliance with cGMP in all aspects of Production and Quality Assurance. The self –   inspection programme is designed to detect any shortcoming in the implementation of cGMP and to recommend    the necessary corrective action.
• Quality Systems: Implementation of robust quality systems to monitor and continuously improve laboratory     processes.
• Compliance Monitoring:  QA ensures that all manufacturing processes, testing procedures, and documentation     meet regulatory standards and guidelines (e.g., GMP - Good Manufacturing Practices).
• Batch Release: QA reviews batch records, testing results, and compliance documentation to authorize the release     of batches of finished pharmaceutical products for distribution.
• Validation and Qualification: QA oversees validation and qualification activities for equipment, facilities, and     processes to ensure they meet predefined specifications and regulatory requirements.
• Supplier and Vendor Management:  QA evaluates and approves suppliers and vendors of raw materials,     packaging materials, and services to ensure they meet quality standards. Quality, price and service are the main     criteria for vendor evaluation. Both the foreign and local vendors are evaluated through systematic procedure.    Vendor evaluation record is maintained in Vendor Evaluation Form.

7. Safety and Environmental Controls:

• Safety Protocols: EDCL QA ensures adherence to safety protocols for handling hazardous chemicals and biological    materials. Proper gowning systems are strictly followed to protect personnel engaged in handling hazardous    chemical, materials, products, etc.
• Environmental Monitoring: Implementation of robust quality systems to monitor and continuously improve    laboratory processes.
• Waste management:  EDCL minimize waste generation at the source through efficient practices and product    design. Its waste management system reduces pollution, conserves natural resources, and minimizes harm to    ecosystems. EDCL maintain safe and environmentally sound disposal methods for waste that cannot be managed    otherwise. It has its own ETP (Effluent Treatment Plant) in every plant. It prevents disease and health risks    associated with improper waste disposal. The solid wastes that cannot be treated in ETP are incinerated at high    temperature. EDCL QA control and overseas the methods to assess the effectiveness of waste management    initiatives and make adjustments as needed.

In summary, the QA of EDCL plays a pivotal role in safeguarding public health by ensuring that pharmaceutical products are safe, effective, and of high quality. It combines advanced analytical technologies, stringent quality control measures, regulatory compliance, and highly trained personnel to uphold the highest standards in pharmaceutical manufacturing.

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