Cgmp & Industrial Management

Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy


Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References

1. C GMP & INDUSTRIAL MANAGEMENT BY- RAGHAV SHARMA M.PHARM (PHARMACEUTICS) 1 ST SEM PARUL INSTITUTE OF PHARMACY, PARUL UNIVERSITY, VADODARA, GUJARAT

2. CONTENT : Current good manufacturing Practices Equipment and their maintenance Production Management Conclusion References

3. GMP & C GMP Good Manufacturing Practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacturing and sale of pharmaceutical products. These guidelines provide minimum requirements that a manufacturer must meet, to assure that their products are consistently high in quality, from batch to batch, for their intended use. CGMP in which "C" stands for "Current" (Current Good Manufacturing Practices) requires companies to use latest technologies and systems that are up-to-date in order to comply with the regulations.

4. Equipment and their maintenance

5. EQUIPMENT & TYPES OF EQUIPMENT WHO GUIDELINES FOR EQUIPMENTS EQUIPMENT SELECTION DESIGN, SIZE, LOC A TION AND CONSTRUCTION OF EQUIPMENT EQUIPMENT CONSTRUCTION EQUIPMENT IDENTIFICATION CLEANING AND MAINTENANCE OF EQUIPMENT CONTENT

6. What is an E quipment..??? Equipment may be defined as a physical entity which is used to carry out a general or specific activity in the plant . Types of Equipment Single piece :- E.g.- tablet compression m/c, a mixer, HPLC, FTIR, weighing balance etc . Integrated system :- E.g.- water demineralizing plants, an air handling system etc.

7. WHO Guidelines for Equipments Equipment must be located, designed, adapted and maintained to suit the operation to be carried out . Equipment should be installed in such a way as to minimize any risk of error or of contamination . Production equipment should be designed, located, and maintained to serve its intended purpose . Production equipment should be designed, so that it can be easily and thoroughly cleaned on schedule basis. Production equipment should not present any hazard to the products.

8. Equipment Selection Selection of equipment has both strategic and financial impact on the companies. It is an essential for any company because it has direct influence on the success of the product facilities by optimum cost, improving quality, safety and reducing environmental hazards . Factor that affect selection of equipment are :- Operating criteria Availability of spares and servicing Maintenance Environmental issues Availability of design & maintenance manuals Cost .

9. DESIGN:- Equipment is made on requirement of user based on URS (User Requirement Specification ). Capacity : In put (holding) and output capacity What material (API etc.) will be processed Which cleaning method will be Used How to validate

10. SIZE:- Batch size / vol. of material decides the size of equipment. Physical dimension: L x W x H of equipment, size of room, avoid difficulties in taking in to room, new wall construction etc. Holding and output capacity, Minimum or maximum volume of material decides size Autoclave for sm a ll scale Autoclave for l a rge scale

11. LOCATION :- Equipment should be located to avoid congestion and should be properly identified to assure that products do not become admixed or confused with one another. Water , steam and pressure or vacuum lines, where applicable , should be installed so as to be easily accessible during all phases of operation. They should be clearly identified . Support systems such as heating, ventilation, air conditioning , water (such as potable, purified, distilled ), steam, compressed air and gases (example nitrogen) should function as designed and identifiable .

12. Equipment construction Equipment shall be constructed so that surfaces that contact components & drug products shall not be reactive or absorptive as it alter the safety, identity, strength, quality or purity of the drug product . The construction material used for parts which are direct contact with products & manufacturing vessels may be stainless steel 316 or Borosilicate glass & tubing should be capable of being washed and autoclaved. Any substances required for operation such as lubricants or coolants shall not come into contact with components, drug product containers closures or drug products.

13. EQUIPMENT IDENTIFICATION WHO Guidelines:- All compounding and storage containers, processing lines and major equipment used during production of a batch of drug product shall be properly identified at all times to indicate their content . Major equipment shall be identified by a distinctive identification no. or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of drug product . Fixed pipe work should be clearly labeled to indicate the contents and, where acceptable, the direction of flow. All service piping and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases and liquids.

14. Production Management PRODUCTION : Production is the method of turning raw materials or inputs into finished goods or products in a manufacturing process. In other words, it means the creation of something from basic inputs . PRODUCTION MANAGEMENT : It brings together the 6M's i.e. men, money, machines, materials, methods and markets to satisfy the wants of the people . It coordinates use of personal, land, building & equipment, including management of inventory assets.

15. OBJECTIVE OF PRODUCTION MANAGEMENT: It's main aim is to produce goods of right quality and quantity by time at minimum cost. It also tries to improve the efficiency of the product . To maintain bonding between employees for converting individual desire to organizational target. For better human resource development

16. Looking after general requirements like :- Location & Surrounding Building Premises Water System Disposal of waste Warehousing area Ancillary area Quality control area Quality assurance area Personals Health, Clothing & Sanitation of workers Manufacturing operations & controls Raw materials Equipment Etc.

17. References Significant Elements Of Production Management In Pharmaceutical Industry: A Review (N.V. SATHEESHMADHAV, ABHIJEET OJHA, SHIVANGI BHASIN Faculty of Pharmacy, DIT University, Dehradun, Uttarakhand, India) Quality Assurance of Pharmaceuticals - A Compendiam of guidelines & related material vol-2 GMP & inspection, published by Pharma Book Syndicate, Page.No .- 6-83 C.V.S Subrahmanyam, pharmaceutical production and management, 1st edition, Vallabh Prakashan, New Delhi, 2011, pp. 292-30 P.P.Sharma, How to practice GMPs: A Review