The drug companies and pharmaceutical trade have to adhere to prescribed rules, standards and business ethics while manufacturing and marketing pharma products as they directly affect the public health.
Next to food, drug is essential and a life saving product. Hence special care and importance must be given to the production and distribution of drugs by the pharmaceutical industry. It is with this in mind , the government has made various amendments to the Drugs & Cosmetics Rule 1945 introducing GMP, said A. Arunachalam, former deputy director of drug control, Government of Tamil Nadu.
GMP requires the pharma companies to manufacture products by maintaining prescribed standards with effective and coordinated use of personnel, land building and equipments in sanitary and clean premises. All the activities pertaining to manufacture have to be performed in a dedicated manner prescribed under regulations. Manufacturers of drugs must realize that adopting GMP is their responsibility, Arunachalam said while delivering a lecture on good manufacturing practices at the School of Pharmaceutical sciences of the Vels University in Chennai.
He said that it was also the responsibility of the Government to ensure that drugs supplied to the public are of good quality and should be made in a facility conforming to GMP. While controlling the various activities of the pharmaceutical industry with an object of circulation of quality drugs, the government should give due importance to the pharma industry because it is making a steady progress in the country. Government should ensure the drugs’ purity and effectiveness, but the control must be at all the stages of production, he said.
The revised Schedule M incorporates apart from general requirements, specific requirements for the manufacture of different dosage forms. It speaks of the requirements for the documentation at every stage of manufacture , validation of process and equipments, SOPs, training programmes, self inspection, quality assurance and sanitations.
In the process of manufacturing and packaging of drugs, GMP covers the areas that include location of the company, buildings, equipments, personnel, components (raw materials), production & control procedures, master formula & batch production records, product containers, packaging & labelling, laboratory controls, distribution records, stability programmes, complaint files, self audit, SOPs, site master file, sanitation and validation.
The law requires that the building for manufacture of drugs should be located in a reasonably clean and sanitary surrounding. It is necessary to have well constructed and designed building with proper layout wherein products are processed without risk of cross contamination and mix ups. The floor walls, partitions, ceiling, window and doors of the building must be smooth and impervious so as to permit efficient cleaning and disinfection.
Provision is to be made for storage (warehousing area) of raw materials, intermediates (semi finished), finished products, packing materials, returned goods, machine and equipments and also for rejected goods. Besides provision is to be made for storing poisons, explosive materials, sensitive items and for storing materials requiring cold storage.
The quality control lab should function in a separate building with provision for physico- chemical test, Instrument analysis, microbiology, chromatography and sterility testing. Equipments for the manufacturing of drugs should be installed in such a way that it must provide adequate space for easy operation and maintenance. Partitions are desirable in places where there is chance of contamination and mix ups. The equipments are of suitable size and accurate for use in any intended measuring, mixing, or weighing operations.
As far as the personnel engaged in production are concerned, the production manager should be a blend of good theoretical knowledge of pharmaceuticals and practical experience in the industry. Further he should have good communication skills, both in speaking and writing for better relation with other people. Experience in formulation process and equipment handling is an added quality.
All containers and equipment used in producing a batch of a drug shall be clearly labelled at all times to identify fully and accurately the contents, and the equipments and contents should be stored and handled in a manner adequate to prevent mix up with other drugs.
Appropriate steps should be taken to minimize the hazard of contamination with micro-organisms in the production of sterile products specially.
Documentation is an essential part of the system and related to all aspects of good manufacturing practices. It requires company policy, site master file, individual responsibility, product specification, master formula records, sampling procedures, validation protocol, packaging records, standard operating procedure (SOP), Batch manufacturing records, distribution records, quality control record, stability records, line clearance records, sanitation records, warehousing records, training records and medical examination records.
Sanitation is an important part of GMP. The manufacturing premises should be cleaned and maintained in an orderly manner to be free from accumulated waste, dust and other unwanted materials .All departmental heads are responsible to carry out sanitation/cleaning of area and equipments under their control. There should be documented procedure for all types of cleaning and sanitation activities.
Ancillary areas such as rest or refreshment room, separate toilets for men and women, change room, work shop area, tools and spare parts room, air lock and water system & HVAC system are also coming under the GMP facilities.