PPMA organizes training course on API issues, Smart Formulations and Quality Management System

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PPMA organizes training course on API
issues, Smart Formulations and
Quality Management System 

KARACHI: Pakistan Pharmaceutical Manufacturers Associaton PPMA) South Zone in collaboration with University of London, School of Pharmacy organized a one day training course on API issues, Smart Formulations and Quality Management Systems here on August 6th 2014. Dr. Khalid Sheikh from University College London and Director of Qualified Person (QP) Course besides Prof. Nadeem Irfan Bukhari from University of Punjab were the two facilitators. The course was attended by over seventy participants from the quality control and production departments from various pharmaceutical companies. M/s PharmEvo in particular played a vital role in this academic initiative.


Dr. Kaiser Waheed Sheikh former Chairman of PPMA presenting mementoes
to the guest speakers Dr. Khalid Sheikh and Prof. Nadeem Iqbal Bukhari
at the training course on API issues, Smart Formulations and
QMS organized at Karachi recently. 

Mr. Khalid Sheikh who has expertise in training the pharmacists in achieving “Qualified Person” status in his presentations discussed many important issues. In the first session he talked about the current rends in pharmaceutical industry in the Europe with special reference to the concept of qualified (QP) person, who is a qualified person and how to become a qualified person, legal duties of QP in patient safety besides collaboration between the MHRA and QP. Issues which were discussed in the next session included issues with API supply chain, regulator’s perspective, bar-coding, temperature control and Falsified Medicine Directive. He then talked about the responsibilities of the qualified person in API, audit of API manufacturer and the testing of API on receipt. He also gave details of a case study of API contamination and later discussed European Union GMP inspections, preparation, data integrity, findings and effective communication. Specifications vs. system performance, data analysis, statistical process control, trend analysis, policing the products to avoid the danger of recalling the “Cash Cow” from the market besides product quality reviews in detail.

In the afternoon sessions, Dr.Khalid Sheikh along with Prof. Nadeem, Irfan Bukhari discussed smart formulations, selection of materials for solid dosage forms based on flow properties of API and recipients, challenges in scale up, following Quality by Design to say Goodbye to regulatory and patient complaints. The last session was devoted to Quality Management Systems and the topic which were discussed included Principles of QMS, supplier management, CAPA, Issue management, QMS in sterile manufacture, environmental monitoring, water systems , training systems besides Qualified person certification processes.


Photographed at the PPMA training course on API issues held at Karachi
recently from (L to R) are Mr. Anis Shah, Dr. Khalid Sheikh,
Mr. Nadeem Rahmat, Dr. Kaiser Waheed Sheikh,
Prof. Nadeem Irfan Bukhari and others.

Internal audit of pharmaceutical industry, Mr. Khalid Sheikh opined, is extremely important. China and India are supplying APIs to many countries all over the world. They are interested in getting their functioning audited but they have no time for the auditors. First of all the competence of the auditors and secondly their integrity, he said, was important. The industry should train its own people in audit by getting audit reports. During the discussion it was pointed out that even countries like Vietnam are now demanding primary packaging material certification. We should not wait for the regulatory authorities to enforce it. We must update our standards as it is our own responsibility. India and Bangladesh has done it and if countries like Vietnam can do it, why we cannot do it in Pakistan? Dr.Khalid Sheikh said that now regulatory authorities overseas are becoming more and more stringent. The problem is that when we test the sample, it is of good quality but when we order and the consignment comes in various containers, one has to test all the containers and invariably at times one of the containers is found to be of below standard. We being the custodians of patient safety then have to face a dilemma and take decision which does not harm the patients. If the qualified person finds it harmful, it must be rejected, he remarked.

Speaking in the concluding session Dr. Kaiser Waheed Sheikh former Chairman of PPMA and chief executive of Medisure International thanked both the experts for their valuable presentations and hoped that the participants must have become much wiser after attending this course which was organized at a very short notice. He was delighted at the response from the participants. Though we had planned for thirty to thirty five, but we had to stop the registration at seventy five which shows the enthusiasm of the people in quality control and production who wish to keep them update and abreast of latest developments in pharmaceutical manufacturing. Even if we produce the best quality medicine and it does not work on patients, it is of no good. It is essential that the products we produce are safe, effective and work in our environment. For some of you, some of the issues discussed during the presentations by the guest speakers, Dr. Kaiser Waheed Sheikh said, may be of too high standard and quality but we have to keep ourselves update. PPMA, he further stated, does not look after the interests of owners of the pharmaceutical industry but it looks after your interests as well by organizing such training courses, workshops to update your knowledge, he added. Later he presented mementoes to the guest speakers while participants of the course were presented certificates.