Dear Colleagues! This is Asrar Qureshi’s Blog Post #626 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
- Self-regulation – The most important factor in quality is self-regulation of all activities. It is most efficient and least expensive. The system of self-regulation is affected through well-defined processes and insistence upon adherence to them.
- SOPs – Standard Operating Procedures are embedded in the pharmaceutical production. Even the most elementary plant would have a set of SOPs. Usually, the SOPs are followed also, at least for production. The compulsion is that dispensing must be done against the standard BOM – Bill of Materials. It is done by the warehouse and production staff under the supervision of a pharmacist. This is the starting point. Later steps of mixing, granulation, compression (for tablets) and coating etc. are all done by lower technical staff overseen by a junior pharmacist. SOPs are the guidance which makes it possible. The SOPs should be expanded to include those activities not hitherto covered.
- Adherence to SOPs is the key to self-regulation. It should be made mandatory, without exception, to follow the SOPs in letter and spirit. Spirit is equally important because processes are run by humans, and they should use their own judgment also in the execution of activities. Even where production processes have been largely automated, the human supervision is not eliminated, more so in quality testing where there is greater human involvement. Machines are run by the humans in most parts of the world. Repetitive processes like car assemblies have been given to robots in more developed countries. Extremely small jobs like microchip, which is now nanochip, are also assigned to precision robots. Pharmaceutical manufacturing requires precision but is still dependent on humans who need SOP guidelines.
- Self-regulation starts from procurement of materials which should be governed by relevant SOPs. Transport and storage should be regulated. Storage of finished products and their dispatch within and outside the country also needs a set of SOPs to follow.
- Self-regulation is essential for implementation of QMS – Quality Management Systems like ISO and GMP. In fact, the spirit of ISO is self-regulation. ISO 9000 and other series require formation of internal audit teams which will ensure compliance to procedures. External audit shall be done may be after a year, but internal audit is done more frequently.
- Quality Management Systems are a good tool to streamline and standardize the working. However, we have done the usual treatment with QMS also. In many, if not most, ISO certified companies, the staff does not even know they have been certified; they are doing what they were doing before. The ISO consultant, the management representative, and few others cook the documents, and the company receives the certification in connivance with the consultant after paying the requisite fee. A consultant justified in these words, “even if there are gaps in the first audit, we get the certification anyway to encourage the enterprise. Later audits are more stringent, and things would get better”. The practice tells that nothing different happens in later audits. Some companies even take the certificate once and refuse to get reaudited. They just paste ‘ISO 9001 certified’ on their label and get away with this.
- QMS certification does not need a consultant, but a consultant has somehow become integral. They make life easy; they bring loads of already prepared SOPs and guidelines which can be copied and adopted without understanding. They suggest various types of corner-cuttings and evasions to make the process easier and quicker. All in all, QMS has not accrued the benefits in Pakistan for which it has been designed.
- The biggest argument of Pharma Industry against self-regulation or QMS or any regulation is cost. They say it incurs additional cost which cannot be recovered because drug prices are fixed by DRAP. A good manufacturer and a bad manufacturer would have the same price in the market, so why incur additional costs? There are two replies to this argument. One, pharma manufacturing is a high-responsibility work, for which you are answerable to public here, even if you do not care about the hereafter. If you think you do not have what it takes to do pharma business, you may opt to leave and do some other business. Two, PPMA is dominated by smaller companies which do not wish to upgrade, and they use PPMA platform to fight, amend, and delay quality policies. They want to stay with the conventional ways and keep earning as much as they can. If PPMA is balanced, it could rally for pricing based on quality structures, so that the companies are encouraged to adopt quality measures.
- Government purchase policy in Punjab, Sind and Balochistan does not recognize quality differences; they just go for the lowest prices. KPK is different, they give premium for quality. If you read through the rules and procedures, these are funnily anomalous. They would ask for international certifications like USFDA, EU GMP and so on; they ask for sources of materials and other such things, but finally decide on per unit price basis. We do not have any USFDA approved unit in Pakistan, but even if there was, it would compete on price in the same way. If the government is serious in protecting and improving public health, it must make policies which encourage quality manufacturers and deter those who do not focus on quality.
Self-regulation is the first, most effective, most economical, and most efficient tool for improving and maintaining quality in pharma manufacturing, or any other industry for that matter. Efforts are needed at public and private level to become more sensitive and focused on it.
To be Continued……
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