Quality Assurance – Paul Brooks

Paul Brooks Quality operations comprise of latest Quality control and Quality in-process control mechanisms. A significant portion of the cGMP regulations pertain to the quality control laboratory and product testing. Paul Brooks’ Quality control lab is engaged in sampling, preparation of specifications, testing of materials and products, preparation of documentation, preparation of raw & packaging material released procedures etc. It also has other duties to establish, validate (with Product development) and implement all quality control procedures, keeping the reference samples of herbs, raw materials and products, ensuring correct labeling of containers of materials and products. Quality Control activities also include monitoring of stability of products (with product development) and participating in the investigation of product complaints. From the very beginning, despite the absence of regulatory mechanisms to control quality operations, Paul Brooks developed its own testing protocols and validation methods.

Its chemistry, pharmacognosy and microbiology sections are well equipped with modern lab instruments including electronic balances, dissolution tester, UV double beam Spectrophotometer, TLC, Electro Thermostatic Water Bath, Melting point apparatus, Stability Chamber, Multifunction Infrared Moisture Analyzer , Refractrometer, Friability tester, Disintegration tester, Viscosity meter, Hardness tester, pH meter, conductivity meter, Hydrometer, Incubators, Autoclave, Polarimeter, Thermostatic Drying Oven, etc. The microbiology section is upgraded and optimized to maintain sterility (Class 100) to test sterile ophthalmic preparations.The quality assurance operations department has implemented Quality inprocess checks throughout the manufacturing process. In-Process Control refers to the checks performed during an activity (it can be manufacturing or packing) in order to monitor and if necessary to adjust the process and/or to ensure that the intermediate or finished product conforms to its specification.

Some of the checks include:

Verification of the status labels on the area, equipments & process containers.
Review of the batch record (Online review).
Cleanliness of the area, equipment and line clearance.
Raw material dispensing verification
Monitoring product attributes like appearance, flow, leakage, container accuracy, volume/ weight variation, avg.wt, hardness, thickness, D.T, friability.
Monitoring environmental conditions.
Ensuring machine setting parameters match with batch records.
Yield verification of various stages of production
Ensuring operators are wearing hand gloves and nose mask during all stages of manufacturing
Environmental Monitoring.
Batch coding checks Etc.