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. An international standard like ISO 9000 is used as a guideline, to ensure that a company’s QA system is both effective and ready to be implemented.
Objectives of Pharmaceutical QA
• Offering the assurance that a healthcare professional prescribing or administering the drug is confident of each unit’s efficacy.
• Protecting the public against potential hazards caused by accidental manufacturing and design defects, or instructions for product usage/storage.
• Making sure of complete compliance with applicable industry regulations, statutes, laws and guidelines.
• Protecting the product and manufacturer against penalties, negative publicity, loss of credibility, fiscal losses, etc.
Importance of QA in Pharmaceuticals
Like the food industry, adherence to international quality standards is crucial for the pharma and biotech sectors because of the direct correlation between product quality and public health/safety. Defects in pharmaceutical drugs raise the risk of compromising consumer health and potentially human or animal life as well.
Effective quality assurance helps organizations build better credibility and consumer confidence, in addition to maintaining adherence to FDA regulations and improving production efficiency and processes. It reduces the chances of negative publicity and impact on sales as well (e.g. if a finished product were to be recalled due to quality defects).
Hence, quality assurance in the pharmaceutical industry offers tremendous benefits in terms of rising profits and a stronger reputation. However, through the lifecycle of a new drug, every aspect of the production process needs to be taken into consideration, whether it individually or collectively impacts product quality.
How Does a Pharmaceutical QA Department Work?
Most companies set up separate QA departments, with the intent to find and correct defects in the development stage (before the final product is ready to hit the market).
Here’s an overview of QA’s role:
• Development Stage – During R&D, checking the qualification of raw material, vendors, testing methods, validation, document control, equipment calibration and operating procedures, personnel recruitment and training, data recording, clinical trials, formulation of API batches and more.
•Manufacturing Stage – These are a few examples of the QA unit’s role during production:
o Preparing, approving and monitoring the implementation of key documents (Quality Policy and Objectives, Quality Manual, Validation Master Plan, etc.).
o Approving an equipment calibration, qualification and maintenance schedule, as well as critical utilities qualification calendar (HVAC, water, gas and power distribution systems, etc.).
o Ensuring that specifications and test procedures for raw materials, packing materials, in-process testing, APIs, stability testing, etc. are all in place.
o 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.
o Ensuring that planned/unplanned changes or deviations are documented, reviewed and analyzed, and recommending studies, tests or validation activities to be performed.
o Logging and responding to customer complaints, supervising the investigation into the cause of the issue, providing an investigation report to the customer, etc.
o Initiating, documenting and investigating market returns, reprocessing (for API batches) or destruction (for finished batches), and informing regulatory authorities about defects found after distribution.
o 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.
o 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.
o Qualifying and auditing calibration service providers for tests and calibrations not performed in-house, reviewing and preparing Quality and Technical agreements for other manufacturing sites.
QA System: The Backbone of Pharma Quality
While the development, manufacturing and marketing of products may involve more than one unit or department, the quality unit is usually independent of production processes.
You could also use specialized departments incorporated in an organizational network to handle the quality system and its related duties. In such a scenario, the QA unit would take on the task of provisioning suitable systems as well as defining them in SOPs (standard operating procedures) and higher level instructions.
Delegating QA functions and decision-making authority to operation departments and personnel is ideal for larger organizations, to help ensure quality on the floor. Top-level management also needs to be involved in the responsibilities of this unit, which may be a combination of QA and QC.