Quality Assurance in Pharma Company
The Quality Assurance department plays a major role in the Pharmaceutical industry. The quality of the products that are manufactured in the production areas from starting to following and reviewing documents from the final release or rejection of every batch of Drug substance and Products for distribution and sale. QA department ensures every stage of manufacturing of the drug substance or drug product and also monitors each processing stage and maintains all manufacturing-related documentation as per BPR, Standard Operating Procedures (SOPs). The most important activity for in-process manufacturing and critical process and quality parameters checks up to batch release. Examples: Clean condition and proper manufacturing area, temperature probes, Pressure, steam, RT water, brine, and Personal protective equipment. IPQA persons monitor the in-process and control. After completing the manufacturing batch process record reviewed all data related to product manufacturing like line clearance, raw materials, temperature times, pressure, chemist signature, any deviations, time delays etc., and a checklist of all the calculations related to Batch Processing Records(BPR). Ex: Yield calculations Type complaint based on quality and safety QA responsible action for the decision taken by HODs as per SOPs. Change Control (CCF): Any changes based on minor or major processes and validation applied required a change control form which the department finally reviewed and approved by QA within timelines. These are two types based on product quality 1) Temporary 2) Minor deviation 3) Major deviation
Deviation: The deviation is the observation of any process-related information that deviates from the standard process or Protocol. These are two types based on product quality 1) Major deviation 2) Minor deviation In case of any out results from testing given Specification Standard testing procedure. QA department investigates to find the root cause of results Out of Specification (OOS): The results are coming out of the specification These are two types of investigations. Phase 1: Laboratory investigation (Quality Control) Phase 2: Full-scale investigation (Manufacturing, warehouse and Safety) and also additional tests required for investigation. Find out the root cause of the results and decide to take corrective and preventive action so these are not repeated in future. Out-of-trend (OOT): The results are within the specification limits but do not follow the previous batch trend results and are also near the specification limits.
it indicates the process is out of control or something the process not properly follow. Whenever any market complaints came for a product or any document received an official email from a customer maintained a registered as per SOP. Internal audits: QA conducts internal audits frequently as per their SOPs to check all departments follow their SOPs. External Audits: (Regulatory and Customer) To conduct an audit by QA of their contract manufacturing units or APIs to check to follow their SOPs, guidelines and policies. Monthly conducts two hours of training oral or verbal or PPT for departments in pharma guidelines and important topics of the industry. After completing training conduct a written examination for participants persons and also an evaluation. Ex: 1) cGMP (Current Good Manufacturing Practice) 2) ICH guidelines (International Council of Harmonisation for Pharmaceuticals Human Use). Annual Product Quality Review: (APQR) Prepare annual product quality review for consistency of the manufacturing process, Quality, yield, and analytical results to be represented statistically. Mainly Quality Management Systems (QMS) activities are followed by Validations (Vendor, Process, Cleaning, Method), Qualifications (IQ, OQ, PQ), Tech transfer, Market and Customer complaints RA department requirements. Conclusion: The Quality Assurance Department have the authority of each department to Audit and implement the cGMP and Pharmaopial guidelines in the Pharmaceutical companies.
