What Cold Chain Solutions Are There and How to Monitor Them [Nathan Roman] Nathan Roman
Temperature Mapping – All You need to Know About Good Qualification Protocol [Nathan Roman] Nathan Roman
Steps to Validating a Temperature Controlled Chamber [Nathan Roman] Nathan Roman
What Is Thermal Mapping and Why It’s So Important [Nathan Roman] Nathan Roman
Paul Palmer April 6, 2020 715 1 5
Quality Assurance Philosophy Paul Palmer
Paul Palmer and Yan Kugel talked about the quality assurance (QA) and Quality Control (QC) philosophy in organizations. Many companies don’t get it right, and it costs them in compliance, time, and money. But it is not too late for any company to change that.
Watch the whole talk :
Manufacturers must understand the core differences and the responsibilities of the QC and QA departments. Here is the simplified model – QA is responsible for the activities before the process (e.g., equipment qualification and process validation). QC would have here only supporting functions. QC is primarily accountable for the actions at the end of the process, within live manufacturing runs. It is there to confirm that results meet the requirements of the validated plan.
A good example is the aseptic manufacturing process, where you must rely mainly on controls that you have in place. You cannot rely exclusively on the sterility test in the end, because you test only a small number of samples.
A company with a proper QA philosophy cannot rely only on QC test results. Instead, they must have full control over the process life cycle. It is not enough to release a product that seems to be in-spec while ignoring the fluctuations in test results that get closer and closer to the action-limit with each day that passes. In order not to lose control over the process, QA must review trend analysis at least every month, always taking the last 12-months into account.
However, there is more to the QA philosophy than the QA department alone. A company must spread the QA philosophy across the organization! Each person must feel the responsibility for the quality of the product and not rely on QC and QA departments to detect problems at the end of the process. Each team, from validation to purchasing, should have its appropriate controls and ways to measure the quality of their part in the process.
For example, the purchasing team must be tightly involved in quality issues. They must understand that they cannot switch production material on a whim, only to save costs. Even if the raw-material has the same name and CAS number, it still may have different properties due to its manufacturing process. Besides, there may be additional parameters which the company didn’t list on the spec sheet, like particle size, for example. Such slight changes in the material specification may cause a tablet to fall apart after a few months.
Therefore, a team of experts must evaluate every material change in-depth and perform test runs, before using it in full-scale manufacturing. A process revalidation may even be required, depending on the critically of the changed material. By avoiding such mistakes, a company won’t waste precious APIs on failed batches, which otherwise may lead to significant capital losses, which could take years to recoup.
To ensure a high-quality product, with minimal losses, a company must implement a Total Quality Management concept throughout the whole organization. It means that every member of staff must be committed to maintaining high standards of work in every aspect of a company’s operations. To implement the concept, a company must first evaluate its current state by mapping their whole business process- from purchasing of raw materials to the finished product, while identifying all the critical control points, and performing robustness tests. Process capability index (Cpk) is an excellent tool to start with for measuring that.
It shouldn’t be extremely difficult for companies that already manufacture a product for years, as they can look at the data they already have – especially the failures (deviations, non-conformances, and complaints). It’s always a good idea to start with the problems, and only then to expend to other sections which you can improve. As soon as you have identified the issues, conduct a proper root cause analysis, and be careful with human-error conclusions.
If you do the job properly, you do it once. If you do it half-hearted, you’re going to do it again next month.
– Paul Palmer
The time it would take companies to implement a total quality management concept would depend on their current state. A company with thousands of deviations a year would have a more challenging journey than a company with only 500. The hardship is, of course, identifying the most critical ones for the process.
As you can see, the whole concept rotates around finding weak points in the system and analyzing deviations or mistakes done by employees. Therefore, for a company to succeed with the transformation to a Total Quality Management concept, it must encourage and reward employees for reporting deviations. Blame is not the answer, especially not in the pharmaceutical industry. Scared employees would prefer to hide mistakes than to report them, which would cause tremendous setbacks in the future. Management should punish those who hide mistakes severely while commending those who document them, especially if it was their own mistakes.
Companies that lack the internal resources to perform a process mapping should consider hiring a consultant to support them with the activities. It is essential to let a party look under the hood because they:
So you decided to bring in external support. How to choose the right one for your needs? This part is tricky, as you someone who would understand the business as a whole. Look someone with a relevant depth of knowledge and training. A graduate won’t cut it. To map the business process, you need someone who has done and seen it all. A qualified person would have an advantage here, or at least someone with a lot of auditing experience. Even if you think that you found the perfect person for the job, implement his work on trial runs to test the results. Additionally, the advisors must work with representatives from each department. That way, you minimize conflicts, make sure that everybody is on board, and, most importantly, keep the knowledge inside the company when the advisor leaves.
In conclusion, take it slowly and step by step. To achieve the best results, you must make sure that everybody is on board. Otherwise, the friction would doom the whole process. Then, start by looking at your past data and map the process to find the weak points. Afterward, look at the cost of the failures and use them to justify the investment. And remember – it ALWAYS pays off!
Information on good manufacturing practices (GMP) in the life science industry is scattered, vague and poorly organized. We have chosen to solve this problem by organizing the best possible GMP webinars and courses to ensure we deliver all the information you need in a concise, engaging and clear format. All events are free and open to anyone in the industry.
Browse Upcoming Free GMP Webinars
Tagged as: GMP, QA, Pharmaceuticals, Pharma, Quality, Compliance, Good Manufacturing Practice.
Paul has been in the Pharmaceutical industry since 1986. He is a pharmaceutical consultant and business advisor. Paul uses this experience to support his clients in meeting the regulatory requirements for existing products and bringing new products to the market.
Copyright © 2023 Qualistery