Dear Colleagues! This is Asrar Qureshi’s Blog Post #624 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 onWordPress, the top blog site. Please email to firstname.lastname@example.org for publishing your contributions here.
February 2022 marked my completing 47 years of working in Pharma Industry. Allah be praised. I am still working. My journey of near half century is also the journey of Pharma Industry in Pakistan. Great changes have occurred in this time and a lot could be written about it. In my blogs, which were started about four and a half years ago, I have covered several topics related to Pakistan Pharma Industry. This multi-part series shall do and review the SWOT – Strengths, Weaknesses, Opportunities, Threats – of the Pharma Industry.
It is now time to strategize, as this was the purpose of this long exercise.
Strategies are made on these parameters:
- Strategies based on Strengths
- Strategies to mitigate Weaknesses
- Strategies to exploit Opportunities
- Strategies to avert Threats
We shall follow the same line of thinking. We have completed Strategy Recommendations based on Strengths.
Strategies to Mitigate Weaknesses
- Improve Quality Standards – An equally or even more important area is quality. Local Pharma industry has come a long way in this area but still a lot of work needs to be done. One reason is that the quality guidelines and standards also keep on moving forward. Our industry also moves forward but the gap is still there.
- Local Pharma may be divided into three tiers of companies. The ones on the top are pursuing quality standards, following guidelines, making effort to keep pace with international standards, and constantly raising themselves up. They are still not there but can hope to be there if they keep the will. Second tier is a large bulk which are following some and not following some standards. They are moving forward though their pace is slow. Third tier is another bulk who still believe all this talk about quality is rubbish and should not be heeded to. DRAP still takes a very lenient view in general, and its officers also hold their independent views. Due to this disparity, the enforcement of quality standards is not uniform. Some of the pharma manufacturing units are in such shabby condition it is hard to understand how they got their licenses or renewals. DRAP can look into their own affairs, but the industry must watch its interests.
- Quality is not understood universally as it should be. Though there are detailed guidelines on concept and application, the understanding is coming slowly. Our biggest argument is that we have been making reasonably good drugs and the patients had been getting well, which means our quality is good enough. Yes, it is so. However, there are several minor but important details which are missing. We are not equipped to test the active ingredients beyond a few tests, and we are totally dependent on the supplier information. We are using many old excipients which the world has discarded. We are still making coated tablets with organic coating which the world discarded long time back and moved to safer, water-based coating. There are many such areas which require change to improve quality.
- QBD – Quality by design is still an alien concept here. It simply means that quality must be included in the design of everything because this is the best way to ensure quality. QBD takes into account another very important area of Risk Assessment and Mitigation which we shall address later.
- People working in quality are old-fashioned. Our standard habit is that we do not regularly upgrade our knowledge. It is extremely easy at this time to refresh and upgrade knowledge; the internet is overflowing with information. Even ten years old graduates behave as if they had graduated thirty years back. A large majority of Quality Control staff has chemistry background. They started as quality control analysts and later became managers and senior managers. While they are good in testing, their overall knowledge about pharmaceutical development is variable. Many of these were reassigned to Quality Assurance when it became popular later. QA has the overall responsibility to make, implement and monitor quality policies, and they do not have to be chemist or even pharmacist, but being a pharmacist gives a better view. Presently, people studying TQM – Total Quality Management are also a good choice for Quality Assurance portfolio.
- Our plant designs do not conform with quality standards. Pakistan does not have a single, qualified architect who could design pharmaceutical plants. There are some consultants who have experience of working in pharmaceutical plants and they have developed an insight. However, they are not architects, and they can only advise on designs based on flow of activities. The bigger issue is that the owners/would-be-owners insist on designing the plants themselves. They even claim they do not need any consultation or advice because they are already the best. They would also insist on making multiple manufacturing sections in limited space which ultimately violates the basic principles and guidelines. With this starting flaw, we cannot take quality much farther.
- DRAP approves the site where pharmaceutical manufacturing plant would be located, and it approves the layout before the construction work is started. Ironically, DRAP or MoH before it did not have any qualified person to do this. The job is done by the regular officers who are not even aware of the basics of plant designs. The result can be seen by visiting the pharmaceutical plants across Pakistan. Many are located in places which are not suitable for this purpose. The plant designs are utterly against all guidelines, but these got approvals before and after and are producing hundreds of medicines and doing roaring business. With this attitude, DRAP is not qualified to safeguard quality of pharmaceutical products. The licenses are given out on whims of the inspectors who had had no training in this area.
To ensure required quality consistently, following measures are suggested.
- Existing Plant designs should be adjusted and modified to bring them as close to guidelines as possible.
- New plants must be designed as per quality guidelines.
- People with appropriate qualifications should be appointed in the right places. The existing staff should be advised to upgrade their knowledge to become eligible for staying where they are.
- Quality is not the responsibility of QA or QC alone; it is everyone’s responsibility. The spirit should be promoted throughout the corporate. Supply chain, finance, production, warehouse, logistics, marketing, and quality staff should be made to consider quality in all their job activities.
- Quality must not be taken by choice; it should be taken by mandate. It is about human lives, and it requires highest level of care and assurance.
To be Continued……
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