Quality assurance department responsibilities

Purpose:

The purpose of this SOP is to provide written guidelines for Quality assurance department responsibilities

Procedure:

Quality assurance department responsibilities

• QA department has the responsibility and authority to approve or reject all raw materials, containers, closures, in-process materials, packaging materials, labelling and finished products.  
• QA department has the authority to review production records to assure that no errors have occurred or if occurred that they have been fully investigated.
• QA department is responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
• QA department has the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength and purity of the drug products.

Facilities for QA Department:

• Adequate laboratory facilities for the testing and approval or rejection of raw materials, containers, closures, in–process materials, packaging materials, finished products and processed water from different sources.                                   
• Well-maintained instrument laboratory with sophisticated instruments are available.
• All equipment’s and apparatus required for analysis are available.
• Chemical / Analytical laboratory is well equipped with required chemicals, solutions, reagents, indicators, glass-wares and apparatus.
• Well-equipped microbiological laboratory marked with aseptic area for sterility and other microbiological testing is available.
• Well maintained, air conditioned animal house facility for housing rabbits and mice is available for Pyrogen and other pharmacological testing.
• Well-maintained controlled room is available for storage of control samples.
• Separate area is available for testing of packaging materials.
• A small library of reference/ technical books is maintained.

Quality Assurance Department Activities

• Raw materials, packaging materials and other materials are received by Stores. Stores then intimates the QA department by giving GRN duly signed by Stores personnel having all details like name of material, its grade, batch no., quantity received, mfg. date, GRN no., challan no., and the date of receipt etc.
• After receiving the GRN, the details are entered in Raw Material/Packaging Material inwards register and the job its allotted to a QA chemist for sampling of received material.
• Q.A. chemist then goes personally to the stores and checks the condition of the consignment and checks other details as per GRN and collects the sample as per SOP for sampling plan & fills the sample observation sheet accordingly.
• The collected sample is then examined and tested for identity, purity, and strength as per the specifications. The material is kept under test should keep under “QUARANTINE” till its analysis gets completed.                                                                     
• Packaging materials are tested as per the respective In-House specifications laid down.
• After completion of the analysis, analyst informs the status of the material to the Stores department.
• If the material is approved, “APPROVED” status is written on GRN and signed by QA I/c and then sent to Stores. The concerned chemist affixes “APPROVED” green colour labels to the consignment.
• If the material is rejected (either partly or totally), “REJECTED” status is written on GRN along with the reasons of rejection signed by QA I/c and then sent to stores. The concerned chemist affixes “REJECTED” red colour labels on the containers.
• QC department conducts chemical tests for raw water (Potable Water), DM    
• water (purified water) and water for injection along with tests for microbiological        
• evaluation (i.e. bio-burden test).
• Environmental control tests are conducted routinely by checking the bio-burden of the surrounding environment using the plate count method, swab testing.
• Line clearance is given for production preparation tanks & pipelines by checking final wash.
• Production department informs QA department to collect bulk samples by giving information through respective BPCR.
• QA chemist collects the bulk sample before volume makeup (slurry sample) and after volume makeup & checks pH, Assay, clarity & gives clearance for filling through proper entries in BPCR.
• QA chemist then collects the filled bottle sample and checks for Assay, clarity, and for physical parameters like filled weight, extracted volume, thickness of bottles, head weight, hangers of bottles etc. are checked  for each cavity of mould .
• Filled sterile bottles are checked for the shape, clarity of the solution and leakage by leak testing.
• Each batch/lot of sterilized bottle is sampled randomly for complete analysis (Physical, chemical, microbiological, LAL/ Pyrogen, sterility testing etc.) as per the pharmacopoeia and also for extractable volume, and particulate matter.
• Entire testing as per laid down specifications, is carried out in quality control laboratory.
• After sterilization, bottles are sent for labelling and packing. Before that IPQC chemist gives line clearance for absence of previous batch residue, label coding, Mfg. date, Exp. date, price and over-wrap sealing.
• If the product complies with the respective pharmacopoeial specifications, a Release Order is sent to production dept. and Finished Goods Stores (FGS).
• QA department maintains records and documents pertaining to all the above mentioned activities.
• QA department carries out validations & calibrations of all instruments and equipments in the Laboratory.
• QA department retains control samples and documents for every batch manufactured.