Quality Assurance:
Quality Assurance (QA) plays an important role in the development of products and services in pharma and biotech, as part of GMPs (Good Manufacturing Practices). QA refers to the step-by-step process of examining whether goods and services meet specific quality, efficacy and safety requirements, as per their intended use.
Here’s an overview of QA’s role:
Training and internal audit: Training and leading the internal audit team for each department, interacting with auditors during external, internal and customer inspections, and intimating management of the observations. Reviewing training records to check if on-the-job and induction training is taking place according to the schedule, and whether QC (Quality Control) analysts are being validated.
Review of Documentations : Checking the qualification of raw material, vendors, testing methods, validation, document control, equipment calibration and operating procedures, personnel recruitment and training, data recording, Preparing, approving and monitoring the implementation of key documents (Quality Policy and Objectives, Quality Manual, Validation Master Plan, etc.). Ensuring that specifications and test procedures for raw materials, packing materials, in-process testing, stability testing, etc. are all in place. Approving an equipment calibration, qualification and maintenance schedule, as well as critical utilities qualification calendar (HVAC, water, gas and power distribution systems, etc.). Reviewing and approving manufacturing records and QC testing data before any intermediate, API or finished batch is released, as well as periodic trending of this data.
o Initiating an OOS (out of specification) investigation and reviewing the QC test if any raw material, packaging, intermediate or stability sample does not meet established and approved specification during the latter.
Market Complaint: Logging and responding to customer complaints, supervising the investigation into the cause of the issue, providing an investigation report to the customer, etc. Initiating, documenting and investigating market returns, reprocessing (for API batches) or destruction (for finished batches), and informing regulatory authorities about defects found after distribution.