Quality Assurance in Pharma Company | QA in Pharma

 

QA in Pharma

• The Quality Assurance Department plays a major role in the Pharmaceutical industry in maintaining QMS, Policies, Good Manufacturing Practices,(GMP) Good documentation Practices, (GDP), Company ethics and Data Integrity of the total 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, and 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, Line clearance and Checklist
• Complaint based on quality and safety QA responsible action for the decision taken by HODs.

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 and safety.
• 1) Temporary 2) Minor 3) Major

Deviation:

• The deviation is the observation of any process-related information, non-conformity, that deviates from the approved procedures or system of SOP, STP, BPR, FPR or Protocol.
• These are two types based on product quality 1) Major deviation 2) Minor deviation
• In case of any process delay or problems investigate the root cause find out and raise CAPA closed proper documentation.

Out of Specification (OOS):

• The test results come out of the specification given data and STP.

OOS 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 action and preventive action (CAPA ) and documentation closed given SOP timelines.

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.
• OOT investigation same as OOS investigation.
• OOT indicates the process is out of control or something the process is not properly followed. 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 schedule to check all departments. It is conducted every six months or Schedule

External Audits: (Regulatory and Customer)

• To conduct an audit by QA of their contract manufacturing units or APIs or Formulations to check to follow their Quality System, SOPs, Agreements,  Data integrity, guidelines and policies.

Trainings:

• On-job training and one hour 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 and submit annual product quality review (PQR) for consistency of the CPA, CQA 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), Equipment Qualifications (DQ, IQ, OQ, PQ), Tech transfer, Market & Customer complaints and Regulatory Authority (RA) department requirements.

 Conclusion:

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

#QA #Chage control #Deviation #IPQA #SOP #STP #OOS #OOT #APQR #Qualifications #Validations #GDP #ISO9001-2015 #MHRA #USFDA #cGMP