GMP (Good Manufacturing Practices) is the most familiar term in pharmaceutical manufacturing. In simple term it is stepwise control of quality at all stages beginning from purchase to storing, utilization of components, manufacturing process, control and up to the end where the products reaches at the hands of consumer. Now cGMP, GMP Audit & advanced GMP have been adopted in manufacture of allopathic product.
Recently, the government has incorporated revised schedule M in Drugs & Cosmetics Rules, which is mandatory for its compliance by all pharmaceutical manufacturers. The existing manufacturers have been allowed a buffer period of 2 years i.e. up to Dec. 2003 for companies of Schedule M. Whereas the provision of GMP was incorporated first time in June 1988 for allopathic medicines.
Similarly for the first time government incorporated GMP for Ayurveda, Siddha and Unani (ASU) Medicines as schedule T in ''Drugs & Cosmetics Rules'' vide gazette notification GSR no. 560 E dated June 23, 2000. The amendment was made with clearcut directives to comply schedule T for getting new licence for the manufacture of ASU medicines. At the same time 2 years of buffer period was provided to existing manufacturers of ASU medicines to comply all the provisions of schedule T. It means all manufacturers have to comply the provisions within June 23, 2002. Now only 2 months are remaining. Hence they must start taking effective steps for its compliance to avoid legal complications.
It can be declared with confidence that the quality of ASU medicines would be improved and products would be of zero defect on implantation of schedule T provision in manufacturing houses. In fact the intention of government is to improve the quality and standard of ASU medicines manufactured in our country. And the main objectives associated with GMPs are:
- To use quality, authentic and specified proper raw material in preparation.
- To maintain standard in manufacturing.
- To follow & control right manufacturing process.
- To adopt quality control of RM and finished products.
- To maintain proper documentation.
- To assure quality finished ASU drugs.
The implementation of GMP will increase the faith of common people besides meeting the requirements of some importing countries, which will ultimately help to small-scale manufacturers export their products.
On going through the details of schedule T, it is observed that the specified standards, clauses space-requirements, documentations, different provisions etc. are moderate and can be easily complied by even small scale manufacturers. It requires intention and attitude of manufacturers. It is too far from standard prescribed in schedule M (earlier GMP requirements for allopathic drugs of 1988).
In summarized form the prescribed specifications of Schedule T can be narrated as stated below for ready references. The specifications are categorized in two parts.
Part I - Good Manufacturing practices
Part II - Requirement of list of machinery, equipment and minimum manufacturing space (A) for Ayurvedic & Sidda system of medicines (B) for unani system of medicines. (B) for unani system of medicines.
Part I - Good Manufacturing practices
Factory premises - The manufacturing plant should have adequate space for
(i) Receiving and storing raw material
(ii) Manufacturing process areas
(iii) Quality Control Unit/section
(iv) Finished goods store
(v) Office
(vi) Rejected goods/drugs store
1.1 General Requirements
1.1 (A) Location and surrounding: The plant shall be so situated as to avoid contamination from open sewage, drain, public lavatory and disagreeable or obnoxious odour or fumes, soot, dust or smoke of any factory.
1.1 (B) Building: Besides compliance of Factory Acts provisions and fire safety measures, provisions shall be made for adequate space, proper room condition, lighting, ventilation, proper drainage system, hygienic conditions in the manufacturing, processing, packaging, labeling, storage-areas. The objective is to minimize any risks of mix-up or cross contaminations. Also provisions are to be made to cover furnace/ bhatti section with tin roof and proper ventilation.
1.1 ( C ) Water supply: Only pure and potable quality of water is allowed in manufacture purpose.
1.1 (D) Disposal of waste: Waste water and residues of manufacturing and laboratories shall be disposed after suitable treatment as per guidelines of pollution control board.
1.1 (E) Container''s cleaning: Adequate arrangements are to be made for washing, cleaning and drying of containers and it is to be separated from manufacturing operations.
1.1 (F) Store: Adequate separate space with proper ventilation and free from dampness are to be provided for storage of raw materials, packing materials and finished products. FIFO (First in-First-out) is to be followed and labels for under test, Approved and Rejected are to be used. If any RM or finished products requires special storage conditions, it should be provided.
1.1 (G) Working space: Adequate space is to be provided for manufacturer & quality control and also for orderly placement of equipment to facilitate easy and safe workings. It is also done to eliminate or to minimize any risk of contamination or mix-up during processing.
1.1 (H) Health, clothing, sanitation and Hygiene of workers: These are to be maintained properly.
1.1 (I) Medical Services: Records shall be maintained for medical examination of employees and all should be free from infection. Arrangement for first-aid is to be made also.
1.1 (J) Equipments: Proper equipments are to be provided and those should be placed orderly manner and also be installed properly. Further proper SOP is to be maintained for cleaning, maintaining & performance of machineries/equipments.
1.1 (K) Batch Manufacturing Records: Proper batchwise manufacturing records are to be maintained for each products.
1.1 (L) Distribution Records: Records of sales & distribution of each batch of all products are to be maintained in proper manner, so as to facilitate any recall of batch, if requires.
1.1 (M) Record of market complaints: Each manufacturer has to maintain a register showing market complaint of their products (if any) and then investigation report and corrective actions to prevent its recurrence. The record of complaints are to be submitted to the licensing authority once in a six months. Reports of adverse reaction of their products are also to be maintained in separate register.
1.1 (N) Quality Control: Each manufacturer has to provide quality control section in their unit. However permission is allowed for arrangement with government approved drug testing laboratory. The testing is to be done as per pharmacoepial specifications. If not available then own specification or authentic specification are allowed. QC has to verify raw materials, process materials & finished products and also manufacturing conditions. Further RMs are to be also monitored for fungal or bacterial contamination & to minimize contamination in finished product. All testing records are to be maintained properly, Controlled samples are to be kept for 3 years. Further provision of a qualified Ayurvedic / Siddha / Unani graduate is to be made for Q.C. section besides other pharmacy/pharmacognosy/chemistry graduate. Space of200 sq. ft. minimum area has been prescribed for quality control.
2.0 Requirement for sterile products: (A) Manufacturing Areas and (B) precautions against contamination & mix up - For manufacture of sterile ASU medicines, sterile room conditions are prescribed i.e. use of HEPA filters, UV lamps, aseptic conditions & conditions to avoid contaminations and for carrying out of routine microbial counts etc. Proper record and SOP are also to be maintained.
Part II - Minimum manufacturing area of 1200 sq. ft. of covered area are to be provided with separate cabins/partitions for each activity besides 200 sq ft for Bhatti and additional 400 sq. ft. is to be provided if unani drugs are to bemanufactured along with Ayurvedic/Siddha drugs. Further name of machineries/equipments required are also specified for manufacture of all types of ASU medicines.
In view of above specified conditions of GMP for ASU medicines and on seeing the coming closer of implementation date, all the ASU medicine manufacturers should start step for its implementation in their own interest. As reported some of the units have already implemented GMP in their units within this year. In rest of the units it can be implemented only if the Chief Executive of firm is committed to it and involves all the white & blue-collar employees representing the entire operation.
Though there is involvement of some cost but in return in provides much more benefit with respect to safe, quality and standard products besides generation of faith & satisfaction of consumer, which is the main objectives of marketing in modern era. It should not be the only duty of drugs control officers to ensure GMP in ASU house but it should be the commitment from ASU manufacturers themselves for its compliance in the interest of mankind.