cGMP as per schedule M

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SCHEDULE M

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PRESENTED BY SUMIT Kumar Mittal M.PHARM(Q.A). 2 nd Semester I.S.F College of Pharmacy DEPARTMENT OF QUALITY ASSURANCE

What is GMP ?:

What is GMP ? GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use. "GMP" - A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality.

What is cGMP ?:

What is cGMP ? Usually see “cGMP” – where c = current, to emphasize that the expectations are dynamic .

What Is Covered in GMPs?:

What Is Covered in GMPs? GMPs Organization & Personnel Buildings & Facilities Equipment Control of Components, Containers & Closures Production & Process Control Holding & Distribution Laboratory Controls Records & Reports Returned & Salvaged Products

GMP Covers…:

All aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff . Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. GMP Covers…

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DRUG AND COSMETIC ACT IN INDIA In 1937 a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drugs Enquiry Committee to regulate the import of drugs into British India. Provincial Governments got the resolution passed from the Provincial Legislatures and sent them to the Central Government for getting through the Bill to regulate the import, manufacture, distribution and sale of Drugs and Cosmetics. There upon the Drugs and Cosmetics Bill was introduced in the Central Legislative Assembly.

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The Drugs and Cosmetics Bill was passed by the Central Legislative Assembly and it received the assent of the Governor General on 10th April, 1940 and thus became the Drugs and Cosmetics Act, 1940 (23 of 1940). An Act to regulate the import, manufacture, distribution and sale of drugs [(Note: Ins. by Act 21 of 1962, sec.2 (w.e.f. 27-7-1964)) and cosmetics].

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DRUG AND COSMETIC ACT 1940 SCHEDULE M

GENERAL REQUIREMENTS:

GENERAL REQUIREMENTS

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1.1 . Location and surroundings .- The factory building(s) for manufacture of drugs shall be so situated that it avoid risk of contamination from external environmental including open sewage, drain, public lavatory. 1.2. Building and premises .- They shall conform to the conditions laid down in the Factories Act, 1948 (63 of 1948)

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The premises used for manufacturing, processing, warehousing, packaging labelling and testing purposes shall be . ( i ) compatible with other drug manufacturing operations (ii) adequately working space to avoid the risk of mix-up between different (b) avoid the possibilities of contamination and cross contamination (iii) designed / constructed / maintained to prevent entry of insects, pests, birds, and rodents. (iv) well lighted, effectively ventilated, with proper Air Handling Units.

1.3 Water System:

1.3 Water System

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There shall be validated system for treatment of water in accordance with standards specified by the Bureau of Indian Standards or Local Municipality or Pharmacopoeial specification. Water shall be stored in tanks, which do not adversely affect quality of water and ensure freedom from microbiological growth. The tank shall be cleaned periodically and records maintained by the licensee in this behalf.

1.4. Disposal of waste.:

1.4. Disposal of waste .

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( i ) The disposal of sewage and effluents (solid, liquid and gas) be in conformity with the requirements of Environment Pollution Control Board. (ii) All bio-medical waste shall be destroyed as per the provisions of the Bio-Medical Waste (Management and Handling) Rules, 1996. (iii) Records shall be maintained for all disposal of waste. (iv) Provisions shall be made for the proper and safe storage of waste materials awaiting disposal.

2. Warehousing Area.:

2. Warehousing Area .

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2.1 Adequate areas to allow orderly warehousing of various categories of materials. 2.2 Good storage conditions 2.3 There shall be a separate sampling area in the warehousing area for active raw materials and excipients. 2.4. Segregation shall be provided for the storage of rejected, recalled or returned materials or products. 2.5 Highly hazardous, poisonous and explosive materials shall be stored in safe and secure areas

3. Production area.:

3. Production area .

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3.1. Separate dedicated and self-contained facilities shall be made available for the production of sensitive pharmaceutical products. 3.2. Orderly and logical positioning of equipment and materials and movement of personnel and to minimize risk of omission or wrong application of any manufacturing and control measures. 3.3. Services lines shall preferably be identified by colours and the nature of the supply and direction of the flow shall be marked/indicated.

4. Ancillary Areas:

4. Ancillary Areas 4.1 Rest and refreshment rooms shall be separate from other areas. Facilities for changing, storing clothes and for washing and toilet purposes shall be adequate for the number of users. 4.2 Animal houses shall be those as prescribed in Rule 150-C(3) of the Drugs and Cosmetics Rules, 1945 which shall be adopted for production purposes.

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5. Quality Control Area. 5.1. QC Lab. shall be independent of the production areas. Separate areas each for physico-chemical, biological, microbiological or radio-isotope analysis. 5.2 Adequate space shall be provided to avoid mix-ups and proper storage for test samples, retained samples, reference standards, reagents and records.

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6. Personnel . 6.1. Qualifications and practical experience in the relevant field. 6.2. Written duties of technical and Quality Control personnel shall be laid and following strictly. 6.3. Number of personnel employed shall be adequate and in direct proportion to the workload.

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7. Health, clothing and sanitation of workers . 7.1 Prior to employment, all personnel, shall undergo medical examination and a periodically examination is carried out, records are also maintained. 7.2 Proper training shall be given to all employees to maintain personnel hygiene and adequate facilities for personal cleanliness. 7.3 Smoking, eating, drinking, chewing , food, drink and personal medicines not permitted in production, laboratory, storage area.

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8. Manufacturing Operations and Controls. 8.1 All manufacturing operations shall be carried out under the supervision of technical staff approved by the Licensing Authority

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8.2. Precautions against mix-up and cross-contamination- 8.2.1. By proper air handling system, pressure differential, segregation, status labelling and cleaning. Proper records and SOP there of shall be maintained.

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8.2.2 Processing of sensitive drugs and cytotoxic substances in segregated areas. 8.2.3 Proper labelling of materials and equipments. 8.2.4 Packaging lines shall be independent and adequately segregated. 8.2.5 All printing and overprinting shall be authorized in writing. 8.2.6 The manufacturing environment maintained at the required levels of temperature, humidity and cleanliness.

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9. Sanitation in the Manufacturing Premises. 9.1 The manufacturing premises shall be cleaned and in an orderly manner. 9.2 The manufacturing areas shall not be used for other operations. 9.3 A routine sanitation program shall be drawn up which shall be properly recorded and which indicate-- (a) specific areas to be cleaned and cleaning intervals; (b) cleaning procedure to be followed (c) personnel assigned to and responsible for the cleaning operation.

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10. Raw Materials. 10.1 Keeping an inventory of all raw materials to be used and maintain records as per Schedule U. 10.2 Authorized staff who examine each consignment for its integrity.

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10.3 Labelling with the following information: (a) name of the product and the internal code reference and analytical reference number; (b) manufacturer’s name, address and batch number; (c) the status of the contents (e.g. quarantine, under test, released, approved, rejected); and (d) the manufacturing date, expiry date and re-test date.

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11. Equipment. 11.1 Equipment shall be located, designed, constructed, adapted to suit the operations and logbook is maintained. 11.2 Equipment shall be calibrated and checked on a scheduled basis in accordance to SOP and maintain records. 11.3 Equipment shall be inert and defective are removed and labelled .

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12. Documentation and Records. Documentation is an essential part of the Quality assurance system and Its aim is to define the specifications for all materials, method of manufacture and control to release a batch of drug for sale.

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12.1 Documents shall be approved, signed and dated by authorized persons. 12.2 Documents shall specify : the title, nature and purpose laid out in an orderly fashion kept up to date. 12.3 SOP shall be retained for at least one year after the expiry date of the finished product. 12.3 Data may be recorded by electronic data processing systems but Master Formulae and detailed operating procedures relating to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records .

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13. Labels and other Printed Materials . Labels are necessary for identification of the drugs and their use. The Printing shall be done in bright colours and in a legible manner. The label shall carry all the prescribed details about the product. 13.1 All containers and equipment shall bear appropriate labels. 13.2 Prior to release, all labels for containers shall be examined by the QC Department. 13.3 Records of receipt of all labelling and packaging materials shall be maintained and unused coded and damaged labels and packaging materials shall be destroyed and recorded.

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14. Quality Assurance. It is a wide-ranging concept concerning all matters that individually or collectively influence the quality of a product. It shall ensure that: - (a) the pharmaceutical products are designed and developed in a way that takes account of the requirement of GMP ,GLP and GCP. (b) adequate controls on starting materials, intermediate products, and other in-process controls, calibrations, and validations are carried out. (c) products are released after authorized persons have certified.

15. Self inspection and Quality Audit:

15. Self inspection and Quality Audit It is for the assessment of all or part of a system with the specific purpose of improving it. 15.1 The program is designed to detect shortcomings in the implementation of GMP and to recommend the necessary corrective actions. Self-inspections shall be performed routinely and on specific ocasions . The team responsible for self-inspection shall consist of independent, experienced, qualified persons from within or outside the company who can evaluate the implementation of GMP objectively; all recommendations for corrective action shall be implemented. 15.2 The procedure for self-inspection shall be documented indicating self-inspection results; evaluation, conclusions and recommended corrective actions with effective follow up program.

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16. Quality Control System. Quality control shall be concerned with sampling, specifications, testing, documentation, release procedures . Materials are not released for use, nor products released for sale or supply until their quality has been judged to be satisfactory.

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16.1 QC lab should have qualified and experience staff. 16.2 QC lab. may be divided into Chemical, Instrumentation, Microbiological and Biological testing. 16.3 The QC department shall conduct stability studies of the products to ensure and assign their shell life . All records of such studies shall be maintained. 16.4 All instruments shall be calibrated and validated before adopted for routine testing. 16.5 Pharmacopoeia, reference standards, working standards, references spectra, other reference materials and technical books, as required, shall be available in the QC Laboratory.

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17. Specification 17.1 For raw materials and packaging materials. They shall include : a) the designated name and internal code reference; b) reference, if any, to a pharmacopoeial monograph; c) qualitative and quantitative requirements with acceptance limits; d) name and address of manufacturer or supplier and original manufacturer of the material; e) specimen of printed material; f) directions for sampling and testing or reference to procedures; g) storage conditions; and h) maximum period of storage before re-testing.

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17.2 For finished products. Appropriate specifications for finished products shall include: - a) the designated name of the product and the code reference; b) the formula or a reference to the formula and the pharmacopoeial reference; c) directions for sampling and testing or a reference to procedures; d) a description of the dosage form and package details; e) the storage conditions and precautions, where applicable g) the shelf-life.

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18. Master Formula Records . There shall be Master Formula records relating to all manufacturing procedures for each product and batch size. These shall be prepared and endorsed by head of production and quality control. The master Formula shall include : - (a) the name of the product together with product reference code relating to its specifications; (b) the patent or proprietary name of the product along with the generic name, a description of the dosage form, strength, composition of the product and batch size; (c) name, quantity, and reference number of all the starting materials to be used.

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(d) A statement of the processing location and the principal equipment to be used. (e) detailed stepwise processing instructions and the time taken for each step; (f) the instructions for in-process control with their limits; (g) the requirements for storage conditions of the products, including the container, labelling and special storage conditions where applicable; (h) any special precautions to be observed; and ( i ) packing details and specimen labels.

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19. Packing Records . There shall be authorised packaging instructions for each product, pack size and type . These shall include or have a reference to the following: - (a) name of the product; (b) description of the dosage form, strength and composition; (c) the pack size expressed in terms of the number of doses, weight or volume of the product in the final container; (d) special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before the operations begin.

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20. Batch Packaging Records . A batch packaging record shall be kept for each batch or part batch processed. It shall be based on the relevant parts of the packaging instructions, and the method of preparation of such records shall be designed to avoid transcription errors. 21. Batch Processing Records. There shall be Batch Processing Record for each product. It shall be based on the relevant parts of the currently approved Master Formula. The method of preparation of such records included in the Master Formula shall be designed to avoid transcription errors.

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22. Standard Operating Procedures (SOPs) There shall be written SOP and records for the : receipt of each delivery of raw, primary and printed material. internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate. for each instrument and equipment. sampling which include the person(s) authorized to take the samples. describing the details of the batch numbering which ensure that each batch of intermediate, bulk or finished product is identified with a specific batch number. testing materials and products at different stages of manufacture, describing the methods and equipment to be used.

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23. Reference Samples 23.1 Each lot of every active ingredient, in a quality sufficient to carryout all the tests, except sterility and pyrogens / Bacterial Endotoxin Test, shall be retained for a period of 3 months after the date of expiry of the last batch produced from that active ingredient. 23.2. Samples of finished formulations shall be stored in the same or simulated containers in which the drug has been actually marketed.

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24.1 Reprocessing and Recoveries

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2. Validation and process validation. Validation studies shall be an essential part of GMP and shall be conducted as per the pre-defined protocols. A written report summarizing recorded results and conclusions shall be prepared, documented and maintained. When any new Master Formula or method of preparation is adopted, steps shall be taken to demonstrate its suitability for routine processing. Significant changes to the manufacturing process, including any changes in equipment or materials shall be validated.

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24. Complaints and Adverse Reactions. All complaints there of concerning product quality shall be carefully reviewed and recorded according to written procedures. Each complaint shall be investigated /evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained. Reports of serious adverse drug reactions resulting from the use of a drug shall be forthwith reported to the concerned licensing authority.

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25. Site Master File. The licensee shall prepare a succinct document in the form of Site Master File containing specific and factual GMP about the production and/or control of pharmaceutical manufacturing preparations carried out at the licensed premises. It shall contain the following: - General information, Personnel. Premises. Equipment. Sanitation. Documentation. Production. Quality Control. Loan licence manufacture and licensee. Distribution, complaints and product recall. Export of drugs.

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References: http://www.medindia.net/indian_health_act/drugs-and-cosmetics-act-1940-introduction.htm www.vakilno1.com/bareacts/drugsandcosmeticsact/drugsandcosmeticsact.htm http://www.dancewithshadows.com/pillscribe/cgmp-regulations-in-india-to-be-diluted/ http://www.prescriptiondrug-info.com/topics/drug-and-cosmetic-act/

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