Pharmaceutical industry: total quality control management.
G.M.P. Laws in Pakistan included requirements regulating the specific criteria for building, equipment, personnel, marketing documentation to be followed for Manufacturing, Quality Control, Record for Production, Quality Assurance Procedures, Packaging, Labelling, Distributing Records, Stability Testing Record, Customer complaints etc.
There is no doubt that GMP enactment has resulted to scientific improvements and development in the delivery of standard Life Saving Drugs of highest quality in Pakistan. Both Drug Control Administration and Pakistan Pharmaceutical industry, deserve the compliments of its whole hearted implementation in Pakistan.
In order to have a clear prospective of the GMP enactment contribution in development of Pharmaceutical Industry in Pakistan, one should view the status of Pharma Industry in Pakistan at the time of its creation in 1947. At the time of independence, in Pakistan, there was no Pharmaceutical unit worth mentioning manufacturing pharma products in this part of the world. Most of the established Pharmaceutical manufacturing units remained in parts of India as in Calcutta, Bombay, Delhi etc. Almost all pharmaceutical requirements were met by imports from India and other foreign countries.
However, in a span of a few years a good number of National and Multinational Pharmaceutical units were established. Today, Pharmaceutical Industry of Pakistan has more than 300 units including 29 Multinationals, catering 80 per cent of Pharma requirements of the country, 20 per cent requirements are supplemented by imports.
Now our Pharma Industry has grown to the extent of having a market of Rs.48 billion approx. in the year 199697. Our industry is fully catering the requirement of standard formulated drugs, but still depends largely on imported raw materials from various multinational sources. At present a few Pharma raw materials as Aspirin, Paracetamol, Ibuprofen, Ampicillin, Amoxacillin, Trimethoprim, Ephedrine and few other materials are being manufactured in Pakistan but there still is a big gap in requirements and supply of materials being manufactured in our country. A good number of active raw materials are still required to be manufactured in Pakistan.
Realizing the economical importance of Basic Manufacturing for our country our Government very sensibly have offered good incentives. In order to attract further investment in raw material manufacturing, Government of Pakistan has recently offered very attractive terms and concessions as Protective duties, duty free import of plant and equipment, import of duty free intermediates, Tax holiday for raw material manufactured in Pakistan.
Our formulated manufactured drugs after achieving self-sufficiency of country requirements, are also being exported to other developing countries of Africa, Middle East, Central Asia, Bangladesh, Nepal, Sri Lanka, Afghanistan, Iran etc. Our exported products international, are competing with multinational products in foreign countries in respect of their quality, efficacy, presentation and are being preferred in competition to Indian products.
Our Pharmaceutical products are strictly manufactured under rigid Good Manufacturing Practices and controls and Pharma plants are inspected by Federal, Provincial Drug Inspectors 2-3 times in a year, conforming GMP being followed by the manufacturer in manufacturing and Quality Control as laid down by World Health Organization.
The licensed Pharma plants are also subjected to detailed inspection by Federal Inspection team once in two years at the time of renewal of Manufacturing Licence and any Manufacturing Plant not complying with GMP requirement, their licence is suspended or cancelled. During last month 15 Manufacturing Licence have been suspended or cancelled due to non compliance of GMP result to some substandard manufacturing of products.
The fantastic growth of Pharmaceutical Industry in Pakistan is the result of coordinated efforts and proper legislation by Drug Control Administration, Ministry of Health, and Pakistan Pharmaceutical Industry. The major expansion of Pakistan Pharma industry has been recorded after the enactment of Drug Act of Pakistan 1976 where GMP was made mandatory as a law. GMP enactment in Pakistan has completely changed basic outlook of the pharmaceutical industry as compared to pre-era of GMP enactment and has brought Pakistan Pharma Industry at par with International Standards.
Under the present conditions one feels proud of our Pharmaceutical Industry working on International, Standard scientific pattern conforming the requirement of GMP. Thus assuring implementations of proper methods of production quality assurance, compounding, packaging and distribution of drugs of highest standards. The strict observance of GMP prevents the rejection of batches, resulting control of losses, increased production and profitability. GMP provides specific guide-lines which also checks the critical operations within the organization following the concept of Total Quality Control System.
GMP is a tool in building the quality in manufacturing of Pharmaceuticals the concept of Total Quality Management. Quality as per ISO is defined as totality of features and characteristic of a product or procedure resulting to satisfaction of the set objectives and requirements of the consumer. Quality is the requirement of the consumer and lack of quality leads to consumer dis-satisfaction, loss of public health, and ultimately the loss of business.
Quality is the outcome of a quality culture in a business organization and GMP is a tool for providing such Total Quality Management Concept. The philosophy of Quality Assurance is an enlarged activity beyond Manufacturing Operations, covering all operations of the organization, described as "TOTAL QUALITY CONTROL", which starts even before start of any operation. The functions of TQC are to plan control, improve and audit of each activity in a manufacturing organization. TQC is extended to link the Suppliers, Manufacturers, Distributors and Customers in the chain of Quality, as such is called Total Quality Management.
Primarily a customer's oriented continuous Quality improvement system involving each member of the team, lowest or highest in the rank. Each member of the team needs to recognize the requirement of the customer, to the fullest satisfaction. TQM is an approach continuous improvement of quality of Goods and Services delivered by co-ordinated efforts of all team members of the organization. TQM is based on the following fundamental concepts:
1. Commitment: It starts with the chief executive of the organization his commitment to TQM and active involvement in promotion and practice of TQM all employees at all levels to make it a success.
2. Customer Satisfaction: To know customer requirement and to coordinate to achieve satisfaction of the consumer.
3. Implication of loss of quality is loss of customer satisfaction, confidence, loss of future business and reputation of organization. Participation by all.
5. Problem, identification and solution of the problem.
6. Personnel accountability and development.
Benefit of TQM
1. Customer Confidence
2. Improvement in reputation and business of organization.
3. Increase in profits - positive organization culture.
The fundamental concept of TQM is fully covered in Good Manufacturing Practice. GMP is a good quality control practice, for the good of customer and is good product liability control for the manufacturer. Both the law enforcing agencies and industry agree that the customer's protection is in the interest of all, for the better product, customer's acceptance and objective of the manufacturer. If we go through the details laid down in GMP, elements considered in TQM are mostly included in GMP, hence GMP compliance also ensures the TQM compliance resulting to standard effective, quality product.