Dear Colleagues! This is Asrar Qureshi’s Blog Post #636 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 and Weaknesses.
Strategies to Avert Threats/Risks
In this last set, we shall discuss strategies that shall help in averting threats and risks. These may be prevailing now and may be coming up in the near future. The nearness of future is important factor, because some of the shadows are already lurking. In the strategic language ‘Clear and Present Danger’ is which is here and now and serious. Some do belong to this category also.
We shall start from the present and move into future.
- Strengthen Quality Operations – QO or Quality Operations is the upcoming concept which is taking over. Previously, Plant Operations was considered as a single block with a single ‘Technical Head’. Production, Engineering, Quality Control, Admin, all reported to him; there was no quality assurance. It was later realized that the Quality Control itself made policies and implemented these. There was no check. Quality assurance was then carved out to create a function which would make quality policies, guidelines, SOPs, and monitored compliance. Risk assessment and mitigation were further added to QA, so were validation and compliance to standards. Another conflict of interest was that the production, QC and QA reported to the same head who had the power to dictate and suppress issues. It was therefore decided that QA would have dual reporting: to the technical head and to the Chief Executive directly. Presently, Quality Operations have been completely separated from Plant Operations with a directly reporting Head of QO.
- Quality operations now include Quality Assurance, Quality Control, Validation, Compliance, HSE – Health, Safety and Environment, and sometimes even Regulatory function. All in all, it is one stop shop for all policies, guidelines, SOPs, and standards that would affect quality of product and quality of humans. The scope of work of QA has been extended to the entire organization. It is said that quality is the responsibility of everyone, not just the Quality people.
- The supply chain is also required to work under guideline of QA. All suppliers must be qualified by the QA before supplies are taken from them. The material specifications must be approved by QA. Change in source Is also subject to QA approval.
- The purpose of making Quality Operations all-pervasive and all-powerful is to ensure that the quality of the product that reaches the patient complies with the pharmacopeial standard. The right of patients to get the standard quality has been accepted as a fundamental right.
- Pharmacopeial standards are being upgraded more rapidly. Mostly, US Pharmacopeia is followed in most of the world and most raw materials are manufactured on USP specifications. Our DRAP is now also specifying that material specification and product specification shall be printed on the packing. The new products which are not yet mentioned in any pharmacopeia shall be manufactured under in-house/manufacturers’ specs. However, these will be shifted to pharmacopeial standard as soon as these are included in it.
- The registration document has changed entirely. As mentioned earlier, CTD – Common Technical Document format dossier is required for registration. For very new molecules additional studies are required about impurities and bioavailability.
- Our Local Pharma is at various stages of compliance vis-à-vis prescribed and new, evolving quality standards. There is a small minority which may be considered fully compliant; majority is non-compliant, and others are in between.
- There is no justification for not following quality standards. It is true for any commodity but for medicines it should not even be considered otherwise. The fact is that the pharma industry keeps getting away with non-compliant practices. DRAP does not come down hard., the government mostly purchases from them due to low prices which makes them ethically justifiable.
- Compliance to quality is not necessarily more expensive. Yes, it requires hiring relevant staff which may be considered additional cost. Otherwise, it entails greater discipline and formality.
The Local Pharma must understand that ultimately the full quality compliance shall prevail. For local market, we may get leeway for some more time, but for international business, the time to comply is now.
Rapid changes in regulatory structure/ requirements are here to take over. It is just a matter of time. Pharma market in Pakistan is already unevenly divided with 50 companies keeping around 90% share. The large chunk of smaller companies shall be further relegated to the margins and may become irrelevant.
It may be mentioned that the DTL – Drug Testing Labs of government have been accredited by WHO and have qualified for ISO 17025, both stringent standards. Many other changes have corrected several issues with the working of these labs. Our inherent corruption persists, but deviations are becoming difficult.
The time to act is now. Local Pharma must work diligently to improve compliance with the required quality standards. This is probably the biggest threat for now and future. PPMA has found that despite their long struggle, they were unable to stop CTD dossier, Pharmacopeial compliance and so on. Standing united on the wrong side does not guarantee victory.
To be Continued……
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