Dear Colleagues!  This is Asrar Qureshi’s Blog Post #796 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here.

Several posts shall be published under this topic, but each post shall be complete in itself.

Quality

Providing quality drugs is the ethical, moral, and legal responsibility of the pharma companies, which they must fulfill in letter and spirit. ‘Letter’ is the detailed documentation as evidence that all involved have done their part responsibly; spirit is the designing of processes, procedures, and trainings to ensure and reinforce quality concepts and practices.

USFDA states, “Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications”. FDA requires all drug manufacturers to monitor quality and drive continuous improvement.

Drug treatment is among the main pillars of medical practice. After a patient has been properly diagnosed, drug treatment is given to relieve/cure the patient, and this would only happen if the quality of the drug is right. We also have abundance of patients with chronic illnesses such as diabetes, heart disease, high blood pressure, rheumatic disorders, benign prostatic hyperplasia and so on, all requiring extended treatment, maybe a lifetime. Quality therefore must be consistent, batch after batch and lot after lot.

Producing and maintaining quality is a constant effort which must be carried on relentlessly so that no deviation takes place. Negligence may lead to tragic cases like the Punjab Institute of Cardiology case causing more than two hundred deaths, and several other such events across the world. For this purpose, detailed guidelines, metrics, and reporting systems have been prescribed by the international health regulatory bodies; constant updating is also done to further strengthen quality aspects.

Who should be responsible for quality of drugs? Present thinking is that quality is everyone’s responsibility, not just Quality Control and Quality Assurance. Presently, the quality structure in pharmaceutical industry stands as follows.

GMP – Good Manufacturing Practices

cGMP – current Good Manufacturing Practices is the overarching document which covers all elements of pharmaceutical manufacturing, i.e., production, quality, storage, distribution etc. Quality is a major element in it and there are detailed guidelines/metrics to ensure quality of pharmaceutical products.

QMS – Quality Management Systems

You have heard of various ISO certifications; each one of these covers the quality of certain aspect of operations. ISO standards are not limited to pharma industry, these are for all enterprises. ISO 9000 series is for quality of management in all departments, ISO 18000 series is quality management of environment, keeping air and water safe; ISO 45000 series is for health and safety of workers; ISO 17025 is for quality in laboratory operations, testing, accuracy of equipment etc.; ISO 15189 is for quality of diagnostic laboratories in healthcare facilities, and so on. QMS provides the umbrella under which further details should be included. Done rightly, ISO certification is a great help in streamlining and organizing the working of any organization. Unfortunately, here and in countries like ours, ISO has been bent to match our working, rather than doing the other way round.

Quality Operations

 More recently, better pharma companies have separated quality operations from production operations. QO now comprises of Quality Assurance, Quality Control, Validation, Product Development, Stability Studies, and Microbiology; PO comprises of production, warehousing, and logistics. Our focus shall be on Quality Operations in this post; production operations shall come later. We shall take up major component of QO separately.

It is important to note that head of QO is now required to report separately and directly, parallel to the head of PO. Head of QO also has dotted line access to the chief executive of the organization so that she/he may not be subject to any pressure or influence.

Relationship between QO and PO

The following steps shall help to understand in easy terms.

  • Before the production could be done, materials must be procured. Quality Assurance – QA defines the specifications of materials which shall be procured. Specs may include both pharmacopeial and non-pharmacopeial parameters.
  • After procurement, quality of every material shall be tested by QC. If accepted, the warehousing under right conditions shall be overseen by QA.
  • An inspector of QA department oversees dispensing of materials for production from the warehouse for production.
  • At every step of production, samples are collected and tested in the In-process lab to ensure compliance with controls.
  • When the product takes the dosage form shape, samples are collected and sent to Quality Control lab for detailed testing.
  • After the product has been declared to be good, the dosage forms, tablets, capsules, injections, syrups, creams etc. are packed and sent to storage.
  • Finished Goods Warehouse is also overseen by QA.

As you see above, all operations are integrated, and quality is ensured at every step.

Quality Assurance

QA has emerged and undergone major changes in the last few decades; previously, everything was clubbed under quality control, which led to conflict of interest in several areas. Role of QA has been expanding constantly, and presently it reaches most parts of the pharma manufacturing and marketing companies.

QA makes policies for implementation of guidelines which are communicated to relevant quarters for implementation, QA monitors compliance.

QA defines quality parameters for materials, storage, transportation, dispensing, product specs etc. which shall be followed by procurement, production, and warehouses.

QA defines environmental control factors, and designs environment-friendly policies. It will also work on setting health and safety standards for workers.

Quality Control

QC is  the other large, important component of QO, which for a long time represented the entire quality.

Quality control works with a set of defined quality parameters and specifications for testing. Their work starts with testing of materials which are procured. All raw and packaging materials are tested by QC and their acceptance/ rejection is subject to QC reporting.

Semi-finished and finished drugs are tested in detail by QC and the production process/ product acceptance is bound with QC reporting.

During product development, QC provides all testing at various stages. Stability Studies testing is also done by QC.

QC shall retain samples from all production batches for the entire shelf-life of the product and one year after. This is a regulatory requirement so that in the event of any complaint, the retained samples could be referred to.

I would avoid further details to keep it simple for non-technical readers.

You would like to ask that if such elaborate quality systems for in place, why any quality issue should ever emerge? Two answers would explain.

One, all processes are run by humans who are likely to make errors due to any of the several reasons, deliberate or mistakenly.

Two, the organizational management explicitly or implicitly may influence the quality operations working in some organization. This is mostly driven by cost saving intent.

Concluded.

Disclaimer: Most pictures in these blogs are taken from Google Images and Pexels. Credit is given where known; some do not show copyright ownership. However, if a claim is lodged at any stage, we shall either mention the ownership clearly, or remove the picture with suitable regrets.

References.

https://www.fda.gov/drugs/development-approval-process-drugs/pharmaceutical-quality-resources#:~:text=Pharmaceutical%20quality%20is%20the%20foundation,and%20effectiveness%20of%20their%20medications.

https://www.pharmaguideline.com/2018/09/what-does-quality-really-mean.html

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4605917/

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