Quality Assurance in Pharmaceutical Industry

Quality Assurance in Pharma Company

• The quality of the products that are manufactured in the production areas from starting to followed and review documents from the final release or rejection of every batch of Drug substance and  Products for distribution and sale.
• The Quality Assurance department plays a major role in the Pharmaceutical industry. 
• This department assures 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 Standard Operating Procedures and vendor Qualifications.
• This is the most important activity for in-process manufacturing and critical process checks.
  
• 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 raw materials, temperature times, pressure, chemist signature, any deviations, time delays etc…
• Checked all the calculations related to Batch Processing Records(BPR) 
  ex: Yield calculations
• Type complaint based QA responsible action for the decision taken 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.

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 action.
  1) Major deviation 2) Minor deviation
• In case of any out of results from testing given Standard testing procedure or method of analysis QA department investigate to find the root cause of results
• These are two types of investigations
• Phase-1: Laboratory investigation (Quality Control)
• Phase-2: Full-scale investigation (Manufacturing or Process side)
• Find out the root cause of the results decision to take corrective and preventive action for 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 to the specification limits.it indicates the process is out of control or something the process not properly follows.
• Whenever any market complaints came for a product or any document by received official email from 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: 

• 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 conducts a written examination for participants persons and also evaluation.
• Ex: 1) cGMP (Current Good Manufacturing Practice)
         2) ICH guidelines (International Council of Harmonisation for Pharmaceuticals Human Use) 

Annual Product Quality Review:  

• To prepare annual product quality review for consistency of the manufacturing process, Quality, yield, and analytical results to be represented statistically.

 Conclusion:

• The Quality Assurance Department have the authority of each department to Auditing and implement the cGMP and Pharmaopial guidelines in the Pharmaceutical companies.