Dear Colleagues! This is Asrar Qureshi’s Blog Post #625 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
- Risk Assessment and Mitigation – During last few years, the concept of risk has been promoted vigorously. The requirement is that all possible risks at all stages of pharmaceutical manufacturing should be anticipated and strategically mitigated. Pharmaceutical manufacturing cannot claim total quality without taking into consideration possible risks and preempting them. Let us see broadly, how do risks appear in various areas.
- Starting from the beginning, i.e., procurement of materials, it is mandated that the vendors should be screened and prequalified before buying materials from them. It would include a visit to their site if possible, or a detailed look at their documentation and certifications, list of customers who are buying from them, certificates of analysis of materials to be purchased, and compliance to pharmacopeial specifications. Next is to stick to buying from approved vendors only, and if a new vendor is to be added, it would go through the same rigorous process. Currently, the observation is that many of the Local Pharma apply none of this; they just buy the materials from whosoever offers less price. Quality Assurance, who is a major stakeholder in this process, is neither consulted nor informed. The patients are being exposed to the risk of low efficacy due to the loss of potency. In addition, there may be risk of unknown health hazards if the materials contain impurities beyond acceptable limits.
- Within the plant, there are many risk areas. Storage is one such area. If the temperature is not maintained as per requirement, there is a risk of loss of potency. Some APIs must be stored at 2-8C, while most need to be stored below 25C. Most warehouses do not have proper HVAC installation to maintain temperature and humidity. At best, few air-conditioners are put up which try to control temperature and humidity. Since thermal mapping is not done, the uniformity of environment in all areas of warehouse cannot be ensured. This is the storage situation in majority of pharmaceutical units. Finished goods warehouses do not even get air conditioning; only industrial fans are installed to keep the temperature low.
- Cold rooms are not available in warehouses where temperature-sensitive, cold-chain products are kept and shipped. Many try to do with ordinary home freezers/refrigerators which are utterly inadequate for the purpose. For years, DRAP looked the other way while companies sold millions of interferon injections through keeping these in home appliances. No one knows what happened to the products and patients.
- Cold chain shipments are another risk area. Temperature reading devices like Temptale® are either not easily available or are expensive. Therefore, these are not used in routine. Cold chain shipments across the country are done with using cool gel pouches or ice plates which are recycled. At one time, dry ice was also used which lowered the temperature initially to minus 20 or so, and then quickly evaporated to let the temperature rise quickly. Both limits were unacceptable. These are all risk areas where the risk assessment is still not being done, mitigation is unthinkable.
- Proper stacking and identification of raw materials is a big risk area. There have been instances where wrong materials were dispensed and caused havoc to patients; the most tragic was PIC Lahore case where Efroze company’s contaminated heart drug led to the death of over 200 patients. The consequences of non-risk-assessment can be serious or even deadly.
- Manufacturing processes also carry risks of human errors and machine errors. Validation of manufacturing processes testing procedures is essential to mitigate risks of errors, however, these concepts are still considered alien in most enterprises.
- Sterile products have additional risks. There are two types of sterile products: one which can be autoclaved for terminal sterilization, such as liquid injections in glass ampoules; the others are those which cannot be subjected to terminal sterilization, such as dry powder vials, temperature sensitive liquid products. Aseptic filling area is required particularly for products which shall not be terminally sterilized. The Bioburden of manufacturing area must be maintained within limits, HEPA filters should be changed regularly and tested for integrity, personnel working inside must be trained to keep the human movements minimum to contain particle content, and so on. Better companies are taking these steps but the same cannot be said with authenticity for the large number of smaller outfits.
- Sterile products must be quarantined for fourteen days, then tested and released if found as per standards. Slight exceptions may be allowed based on the history of manufacturing and validation of processes. The risks associated with not following stringent requirements are many and unknown.
- Packaging materials are subjected to very elementary kind of testing which is not enough to ensure consistent quality. Sources of packing materials are changed with blatant impunity.
- Plant designs may have built-in risks for personnel and products which must be evaluated and quantified and mitigated.
The question is why risk assessment and mitigation are not getting the attention they deserve? Following reasons may be considered.
- Quality Assurance staff is not trained and well-versed with the concept and its application. DRAP did make an effort to train industry people, but the achievement was limited. As mentioned earlier, most of the QA staff does not keep themselves updated. No one stops them, it is a just a habit.
- The entire plant staff is not very receptive to the idea of risk. They realize its importance but think it is too much hassle.
- The entrepreneurs are not interested is spending money to avert risks. They do not care about patients; they care about profits.
- Finally, we do carry a fatalistic attitude and we put everything on fate and luck. Fate and luck work better when we do our part of the job first.
To be Continued……
Disclaimer. Most pictures in these blogs are taken from Google Images which does not show anyone’s copyright claim. However, if any such claim is presented, we shall remove the image with suitable regrets.
Well done proud of you and congratulations