Putting Quality Management System in place will ensure quality


 Seminar focusing up gradation of cGMP in Pharma Industry at IBA

Putting Quality Management System
in place will ensure quality

Product, Manufacturing processes needs to be regularly
reviewed and commitment of top leadership is essential

Quality must be aligned with the basic strategy
and every process should be documented

KARACHI: Center for Executive Education at Institute of Business Administration Karachi organized a seminar focusing up gradation of current Good Manufacturing Practices in the Pharma Industry on Saturday October 22, 2016. It was very well attended by representatives from the Pharmaceutical industry. Ms. Bilquis Yasmeen in her presentation on current Good Manufacturing Practices- leading to Process Excellence discussed at length the challenges in the area, regulatory trends and how to move forward in the current situation. It was followed by interactive discussion.  During the deliberations it was pointed out that Quality Management Systems should be put in place which will ensure quality and it was also important to regularly review the product and the manufacturing processes.

Mr.Izhar Hussain Director Center for Executive Education in his introductory remarks said that in 1970s Pakistan was much ahead of many countries in this region but now the gap has widened. There are about six hundred seventy licensed drug manufacturers and generally we do not comply with GMP validation, documentation that is why we do not have a single FDA approved drug manufacturing facility in Pakistan. Over the years there has been lot of evolution in this field. Our neighboring country India has a market of two billion US dollars in Nigeria while our total exports were just between 170-200 million US dollars. Accreditation and certification are expensive and we are not aware of many things. Clinical Trials was yet another area and we have a very big market. The objective of today’s seminar, he said, was to discuss these issues and find out what sort of training courses should be designed  which could meet the needs of the personnel needed by the pharmaceutical industry. It will also help us in increasing our drugs exports.

Ms. Bilquis Yasmeen pointed out that development in the pharmaceutical industry was linked with tragedies. She then referred to the Thalidomide tragedy of 1960s wherein it was given to patients for morning sickness and it lead to birth of more than sixteen thousand babies with deformity. The product had conformed to the quality control. This drug was not allowed to be marketed in USA and the official in the drug regulatory affairs who had stopped its registration and availability in United States was honoured by the authorities as it had saved the United States.  She also referred to the Isotab contamination in 2012 which rustled in the loss of over one hundred fifty precious lives at Punjab Institute of Cardiology at Lahore. Quality it was further stated must be aligned with the basic strategy and every process should be documented. However, sometime people do not adhere to SOPs for documentation.

There are too many regulations by various organizations for cGMP compliance which includes WHO, Code of Federal Regulations by FDA, European Union like EUDRALEX, UK Medicines and Healthcare Regulatory Agency besides Drug Regulatory Authority of Pakistan (DRAP) etc. It was emphasized that system should be adhered to all the time and it should be the way of life.  Regulatory requirements on Quality Systems  require that “ the license holders shall establish and implement an effective Quality Assurance System involving the active participation of the management and personnel of the different services involved.” FDA Quality Systems Approach to Pharmaceuticals GMP says that “A quality system should address the public and private sector’s mutual goal of providing a high quality drug product to patients and prescribers. A well built quality system should prevent or reduce the number of recalls, returned or salvaged products and defective products entering the markets”. Similarly Vision statement on Quality systems for continuous improvement requires “Developing a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to risk management and science.”

Dr. Kaiser Waheed Chairman PPMA opined that any new personnel on joining should be introduced to the systems working in the organization. Currently there is no institution in Pakistan which provides modulator training. Prof. Arif Siddiqui said that there are seventy four institutions imparting pharmacy education, Pharmacy Council of Pakistan looks after all this but the standard of training varies from institution to institution. It was also pointed out that it was not essential to have pharmacists at the manufacturing facility, what is needed was discipline, sciences and following the laid down procedure. We must realize that the way we do thing puts the reputation of the system at stake; Healthcare is a different industry wherein one deals with human lives. It is also possible that there are some dangerous persons who might indulge in such acts of sabotage leading to serious tragedy intentionally. Every person working in the Pharma industry needs to be careful.

Mr. Zahid Saeed pointed out some bitter facts and ground realities and asked what the motivation was keeping in view the international scenario. New generation of drug regulators, he opined, was not only more efficient but also more honest. DRAP officials unfortunately do not understand the global developments. He was of the view that first of all DRAP should get itself accredited by acquiring the services of qualified people but they do not wish to expose themselves to the international agencies as they are afraid of it. Pharmacists coming out of the pharmacy schools have no training in the products. It is essential that DRAP should expose itself to international standards. Pharmacists needs on the job training. The new generation of pharmacists is not aware of regulatory environment. If those already in business in the country are not happy with the working environment, how the Government can attract more foreign investment. Price, it was further stated, was a major factor. Under the circumstances pharmaceuticals is the most over regulated industry in Pakistan hence without any incentives, how one can go for quality and make further investments because quality needs price.

DRAP it was suggested should have its own talent pool. Mr. Izhar Hussain stated that let us create our own manpower. Academic and intellectuals have no role in making policies which are formulated by the bureaucrats. All these issues do have an Impact on Quality. cGMP means assuring the consistency of quality and its prime objective is to “ensure that products are manufactured batch upon batch to the appropriate and consistent quality standards and in accordance with regulatory requirement by requiring that there was a pharmaceutical quality system”. Having a quality management system was not a new concept but it requires market authorization holders to regularly review their products and their manufacturing processes. Continuous improvement has always remained an essential requirement of Good Manufacturing Practices. Quality is not an act but it should be a Habit. Leadership should take responsibility for failures and whenever principles of quality are broken it can lead to disasters.

Giving details of the current scenario Ms.Bilquis Yasmeen said that our drug exports are decreasing.  Profit margins have considerably reduced and were much less i.e 12% as compared to 30% globally. By 2017, 50% of the drugs volume is forecast to be in   markets while USA and Europe will account for only 13% of the total pharmaceutical volume. BRICS countries will account for 70% of all pharmaceutical market sales. Leadership it was further stated was essential to establish and maintain a company wide commitment to quality and for the performance of the pharmaceutical quality system.

Operational personnel Ms. Bilquis Yasmeen said should be groomed professionally to facilitate deployment of quality system. We need implementable business solutions which enables business in international markets. We must adopt best practices to retain and excel in exports. cGMP training and deployment have to be aligned with company’s objective and designed as methodology making business performance compliant, better, faster, lower cost and safer.

Dr. Minhaj Kidwai summing up the discussion said that the issues which have been highlighted include patient satisfaction, quality of drugs and quality of care. Individuals, institutions and industry are all important. The system must flourish; we must have a positive approach and move forward. Participating in the discussion Dr.Kaiser Waheed highlighted the importance of developing human resource. After the MNCs departure we are unable to develop our people while in the past these multinationals provided a useful resource for training of personnel in different fields. We must develop some institution where manpower required by the Pharma industry must be trained. We need to develop human resource to meet our objectives and needs of the Pharmaceutical industry. Mr. Zahid Saeed stated that we need to have some challenging targets.  Mr. Arshad Rahim in his concluding remarks said that efficiently running one’s enterprise and achieving its mission was the biggest Corporate Social Responsibility. We must look at our potential and do whatever we can do of which we are capable of, he remarked.