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Unit 2 organization and personnel and permisies himanshu

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pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores 
Storage conditions 

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Unit 2 organization and personnel and permisies himanshu

  1. 1. Himanshu Kamboj Assistant Professor
  2. 2. CONTENTS • Personnel objectives • Personnel qualifications • Personnel responsibilities • Key personnel • Responsibilities of the head of the production department • Responsibilities of the head of quality control department • Training • Personnel hygiene • Premises • Layout of pharmaceutical industry • Areas of premises • Environmental control in sterile areas • Equipment and raw materials • Stages of equipment • Cleaning and maintenance • Raw materials • Steps involved in purchase procedure • Maintenance of stores • Storage conditions
  3. 3. PERSONNEL OBJECTIVES • To review requirements for key personnel • To review the training of personnel • To consider some specific issues
  4. 4. PERSONNEL QUALIFICATIONS (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or holding of drug product shall have the education, training, and experience, or any combination thereof to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
  5. 5. PERSONNEL RESPONSIBILITIES (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. (b) Personnel shall practice good sanitation and health habits. (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas. (d) Any person shown at any time (either by medical examination or by supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
  6. 6. PRINCIPLE • The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. • For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. • Individual responsibilities should be clearly • understood by the individuals and recorded. • All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
  7. 7. General • The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. • The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
  8. 8. General • The manufacturer must have an organization chart. • People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities.
  9. 9. General • There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice. • All responsibilities and roles are defined in GMP in Chapter 2 and Annex 16(certification by a qualified person and batch release)
  10. 10. Key Personnel • Key Personnel should possess the qualification of a scientific education and practical experience required as per national legislation. • They are specialized in appropriate and combination of chemistry or biochemistry, chemical engineering, microbiology, pharmaceutical science and technology, pharmacology and toxicology, and other related science. Key Personnel include: • The head of production • The head of quality assurance • The head of quality control
  11. 11. Responsibilities of the Head of the Production Department • to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality • to approve the instructions relating to production operations and to ensure their strict implementation • to ensure that the production records are evaluated and signed by an authorized person before they are sent to the Quality Control Department • to check the maintenance of his department, premises and equipment
  12. 12. • to ensure that the appropriate validations are done • to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
  13. 13. Responsibilities of the Head of Quality Control Department • to approve or reject, as he sees fit, starting materials, packaging materials, and intermediate, bulk and finished products • to evaluate batch records • to ensure that all necessary testing is carried out • to approve specifications, sampling instructions, test methods and other Quality Control procedures • to approve and monitor any contract analysts • to check the maintenance of his department, premises and equipment
  14. 14. • to ensure that the appropriate validations are done • to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
  15. 15. Joint Responsibility • the authorization of written procedures and other documents, including amendments • the monitoring and control of the manufacturing environment • plant hygiene • process validation • training • the approval and monitoring of suppliers of materials • the approval and monitoring of contract manufacturers • the designation and monitoring of storage conditions for materials and products • the retention of records
  16. 16. • the monitoring of compliance with the requirements of Good Manufacturing Practice • the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
  17. 17. TRAINING Trained personnel=quality performance =Continual improvement  Less prone to errors  Less deviations from standards  Reduce amount of rework  Reduce amount of rejects
  18. 18. TRAINING • The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product. • Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training. • Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.
  19. 19. PERSONNEL HYGIENE • Detailed hygiene programs should be established and adapted to the different needs within the factory. • They should include procedures relating to the health, hygiene practices and clothing of personnel. • These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas.
  20. 20. • All personnel should receive medical examination upon recruitment. • It must be the manufacturer’s responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturer’s knowledge. • Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.
  21. 21. • Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out. • Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited
  22. 22. • Direct contact should be avoided between the operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the products. • In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected, should be forbidden. • Personnel should be instructed to use the hand-washing facilities.
  23. 23. PREMISES
  24. 24. INTRODUCTION • Any building used in manufacturing, packaging or holding of drug product must be located, design, constructed, adapted and maintained in such way that operations to be carried out within them, done by fluency and ease • The factory building used for manufacturing of drug product shall be so situated and shall have such measures to avoid the risk of contamination from external environment including open sewage, drain, public lavatory or any other factory producing disagreeable or harmful fumes, odour, dust and smoke, chemical or biological emission. • The Premises/ building used for factory shall be designed, constructed, adapted or maintained to suit the manufacturing and other operations so as to permit production of drugs under hygienic conditions. • The premises/ building shall conform to all conditions laid down in Factories act 1948. • The premises used for manufacturing, processing, warehousing, packaging, labelling and testing should be compatible with manufacturing operations carried out in same area.
  25. 25. LAYOUT OF PHARMACEUTICAL INDUSTRY Adequate space should be provided for logical and orderly placement of equipment and free movement of staff to avoid the risk of cross contamination.
  26. 26. • Proper drainage and waste disposal system should be there and the system should be designed to avoid the back- flow and entry of rodents and insects to the manufacturing areas. • The walls and floors of the areas should be free from cracks to avoid dust accumulation. • The walls and floors should be smooth and washable to facilitate ease of cleaning in the areas. • Electric supply, lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect directly or indirectly either the pharmaceutical product during their manufacturing and storage of the accurate functioning of the equipment.
  27. 27. AREAS OF PREMISES 1. Ancillary areas: Ancillary areas covers: • Rest and Refreshment rooms. • Toilets and Washrooms. • Clothes storage areas. • Changing rooms for employees. • Rest and Refreshment Rooms should be separate from other areas. • Facilities for Toilets should not communicate directly with production or storage areas. • Areas for change rooms and storage of clothes and for washing, and toilet purpose should be easily accessible and appropriate for the number of users.
  28. 28. 2. Warehousing Areas • Storage areas should have sufficient capacity to allow orderly storage of the various categories of materials and products like: i. Raw materials. ii. Packaging Materials. iii. Intermediates. iv. Bulk and finished products. v. Products in quarantine. vi. Released, returned, rejected and recalled products. • Storage areas should be designed to meet the required environmental conditions like: Temperature and Humidity and Records of such environmental conditions monitoring should be maintained. • Separate sampling areas should be provided for active and raw materials, Such sampling cubicles may be designed with suitable size and also provided with cleaning, drying and storage for sampling tools. • Sampling of liquid materials, solvents, flammable materials or toxic, poisons or potent materials should be done in separate areas with taking all the necessary precautions for Safety of people and materials both. • All returned, rejected and recalled materials must be stored in lock and key and necessary precaution should • Printed packaging materials are considered critical to the conformity of the pharmaceutical product to its labelling and special attention should be paid to the safe and secure storage these materials. • Dispensing areas should be separate for active and raw materials.
  29. 29. 3. Production Areas • General category products (other than antibiotics, cytotoxic and hormones,) should be manufactured in separate manufacturing facilities. • Highly potent, sensitive or live micro-organism etc. should be produced in separate areas to avoid cross contamination. • Premises should be designed to have logical flow of materials, well organized layout of plant and machinery and ease of cleaning, both equipment and facility. • Depending on the volumes of materials being handled, adequate space should be provided to avoid mix-ups. • Production areas should be effectively ventilated with suitable designed HVAC system appropriate to products being handled; to the operations undertaken and to the external environment. • Production areas should be regularly monitored during production and non- production periods to ensure compliance with their design specifications. • Premises for packaging of pharmaceuticals should be specifically designed and out so as to avoid mix-up and cross contamination.
  30. 30. 4. Quality Control Areas • Q.C. laboratories should be separate from production areas. • Areas where biological, microbiological, or radio isotope test methods are employed should be separate from each other. • Q.C. laboratories should be designed to provide facilities for: i. Chemical analysis ii. Instrumental analysis. iii. Microbiological and biological analysis etc. iv. Storage for control samples, glassware's, chemicals, microbiological media books, documents etc. v. A separate room or area should be provided where highly sensitive instruments area handled to protect them from electrical interference, vibration, contact with excessive moisture, and other external factors.
  31. 31. Drainage system • Potable water shall be supplied under continuous pressure in a plumbing system free of defects that could contribute contamination to any drug product. • Water not meeting such standards of regulatory guidelines shall not be permitted in the potable water system. • Drains shall be of adequate size. • Drainage should be connected directly to the sewer and it should be provided with an air break or other mechanical devices to prevent back Spoilage. • Drainage system maintenance in the manufacturing facilities is very critical from the Point of view of cleaning and sanitation of the facilities. • A detailed SOP should be there for cleaning and sanitation of drains and their records should be maintained and reviewed periodically.
  32. 32. Disposal of Waste • Sewage, waste and biomedical waste in and from the building premises shall be disposed of in a safe and sanitary manner according to the laws. • The disposal of sewage and effluents (solid, liquid, and gas) from the manufacturing premises should be done in conformity with the requirements of the Environment Pollution Control Board. • All biomedical waste shall be destroyed as per the provision of Bio-Medical Waste and Handling) Rules, 1996. • Additional precautions shall be taken for the storage and disposal of rejected drugs/ materials and all the Records shall be maintained for disposal of waste. • Provisions shall be made for proper and safe storage of waste materials awaiting disposal. • 'Hazardous, harmful, toxic substances and inflammable materials shall be stored in suitably designed and separate enclosed areas in conformity with Central and State Legislation. • Records of all disposed material must be kept and should be available for inspection or audit when required.
  33. 33. MAINTENANCE • Any building, premises used in the manufacture, processing, packing or storage of a drug product shall be in a good state of repair. • Facility maintenance includes maintenance of following things: i. Leakage from ceiling or other surfaces. ii Leakages from pipe lines of waters, steam, gases etc. iii. Plumbing problems. iv. Loose or broken tiles. v. Improper closing of doors, windows. vi. Improper electrical wiring vii Improper electrical fittings/ fixtures. • A detailed check list may be prepared for maintenance. • During routine inspection of the facilities the deficiencies should be identified and corrected immediately and the facility must always be maintained in a state of good. • Deterioration of building and facilities represents poor image of facilities and it can affect product quality. • Cracks/ holes in walls, ceilings etc. can provide access to the rodents, insects, microorganisms and it can directly affect the quality of the product, sanitation and hygiene. • Roof leakage can affect the quality of materials and may cause damage to the equipments. • Hence all the facilities should be checked regularly and maintained and records related to it should be maintained.
  34. 34. SANITATION • "Any building/premises used in the manufacture, processing, packing or holding o a drug product shall be maintained in a clean and sanitary condition". • All the premises shall be free of infestation by rodents, birds, insects, and other vermin' (other than laboratory animals). • There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment and materials to be used in the cleaning the buildings and facilities; such written procedures shall be followed • There shall be written procedures for use of suitable Rodenticides, insecticides, fumigating agents and cleaning and sanitising agents. • Such written procedures shall be designed to prevent the contamination of equipment, components, drug product container and closures, packaging, labelling material or drug products and shall be followed. • Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticides, Fungicides and Rodenticide Act. • Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full time employee during the ordinary.
  35. 35. • SOPs should be available even for cleaning and sanitation of external areas of the facilities like roads, lawns etc. • In pharmaceutical industries, operations have to be carried out in clean areas to avoid contamination, cleaning of areas, equipments and microbial monitoring, disinfection of areas and equipments are very important and have to be carried out regularly. • In order to maintain sanitation and cleaning we have to consider following points i. Create and maintain safe working environment. ii. Remove dust and dirt which can affect product quality. iii. Minimize the risk of cross-contamination occurring between products. iv. Lastly, reduce the levels of microbial contamination.
  36. 36. ENVIRONMENTAL CONTROL IN STERILE AREAS Sterile products are very critical and sensitive in nature hence it requires very high degree of precaution and prevention is required in its preparation and there shall be strict compliance with standards prescribed by regulatory authorities. 1. Air handling units for sterile product manufacturing shall be different from those of other areas. 2. Critical areas such as aseptic filling areas, sterilised components unloading areas and changing room should conform to grades B, C and D respectively and shall have separate "Air handling units". The filter configuration in the Air handling unit shall be suitably designed to achieve the grade of air
  37. 37. 3. For products which are filled aseptically, the filling room shall meet Grade B condition at rest. 4. The Filling operation shall take place under Grade A condition which shall be demonstrated under working of simulated conditions which shall be achieved by providing Laminar air Flow work station with suitable HEPA Filters. 5. For products which are terminally sterilized, the filling room shall meet Grade C conditions. 6. Manufacturing and component preparation areas shall meet Grade C conditions. 7, After Completion of preparation, Washed components and vessels shall be protected With Grade C background. 8. The minimum air changes for Grade B and Grade C areas shall not be less than 20 air changes per Hour in a room with good air flow pattern and appropriate HEPA filters. 9. For Grade A Laminar air Flow work stations, the air flow rates shall be 0.3 meter per second (For Vertical air flow) and 0.45 meter per second (For Horizontal ail flow). 10. Differential pressure between areas of different environmental shall be
  38. 38. 11. Unless there are product specific requirements, temperature and humidity in the Aseptic areas shall not exceed 27◦C and 55% Relative Humidity respectively. 12. All the parameters listed above shall be verified and monitored at regular periodic intervals. 13. Recommended frequencies for Periodic monitoring shall be as follows: • Particulate monitoring in Air : 6 monthly • HEPA Filter integrity testing : Yearly • Air Change Rates : 6 Monthly • Air Pressure differential : Daily • Temperature and Humidity : Daily • Microbial monitoring : Daily 14. There shall be written environmental monitoring programs and Microbiological shall be recorded.
  39. 39. UTILITIES AND MAINTENANCE IN STERILE AREAS • Sterile areas/ aseptic processing areas should have: 1. Smooth and easily cleanable Floors, 'Walls and Ceilings. 2. Temperature and humidity controls. 3. Air supply with HEPA filters under positive pressure. 4. Environmental conditions monitoring system. 5. A system for Cleaning and disinfecting to produce aseptic/ sterile conditions. • Floors, walls and ceilings of sterile areas should be subjected to intensive and frequent cleaning and sanitation. • Floors, walls and ceilings of sterile areas should be composed of smooth and hard surfaces with minimum joints and should be resistant to abrasion. • Temperature and humidity in the sterile areas should be controlled and maintained according to operations performed (68◦F temperature and 45% Relative Humidity is suitable). • The air in sterile areas should be provided by air supply fitted with HEPA filters (less than 100 particles of 0.5 Micron with Not more than I Cfu/cm3); air flow rate 90 feet/ minute is recommended. • Sterile areas should have positive differential pressure related to adjoining areas and "Air pressure differentials should be monitored automatically. • HEPA filters should be tested at regular intervals. • Cleaning and disinfection of sterile areas, Facilities and equipments should be done regularly and procedure used for cleaning and disinfection must be validated with respect to both removal of previous product contamination and effective disinfection, disinfectant should be changed periodically to minimise the possibility of microbial
  40. 40. CONTROL OF CONTAMINATION IN STERILE AREAS • There are two main Sources of Contamination i.e. Area/Facilities and People. 1. Control of Contamination — Areas/Facilities i. In the areas/ Facilities where sterile products are manufactured air should be supplied under positive differential pressure with HEPA filters designed to keep Microorganisms and other particles at low level. ii. In sterile areas all the surfaces of floors, walls, ceilings etc should be hard and free from cracks to avoid dust and microorganism accumulation and should permit easy cleaning. iii. Access to sterile areas must be Controlled/ Restricted to people and entry and exit to sterile areas should be only permitted through change areas. 2. Control of Contamination — People All the personnel working in aseptic/sterile areas should emphasize on following points to control the contamination: i. Keep Body, hair, face, hands and nails clean. ii. Report illness, injury, respiratory and skin problems. iii. Follow the written changing and wash-up procedures. iii. Do not use cosmetic and wear jewellery and wrist watches. iv. Do not take papers and documents in sterile area. v. Avoid eating, chewing, drinking and smoking in sterile areas. vi. Avoid coughing and sneezing (If it is unavoidable, please leave the sterile area). vii. Use gloves and disinfect them regularly. viii. Follow the written changing and wash-up procedures.
  41. 41. ix. Always check on worn and damaged garments. x. Unless there is a special hazard, do not pick anything from floor. xi. Keep talking to the minimum while working in sterile areas. xii. Do not move vigorously, always move gently and steadily. 3. Control of contamination by cleaning and disinfection i. The written procedures regarding Cleaning and disinfection should be followed exactly and strictly. ii. Before disinfection, it is necessary to clean the area completely. iii. All the cleaning and disinfecting agents and materials themselves should be clean. iv. Avoid cleaning by mops use equipments. v. Use vacuum cleaners for sucking dust. vi. Always start cleaning walls and ceiling from top to avoid recontamination. vii. Special care should be taken for selecting right Cleaning and disinfecting agents in right dilution. viii. All the equipments and accessories must be cleaned after used and stored in clean dry place. ix. Split materials such as liquids, Powders should be cleaned in such a way to minimize the risk of further contamination and if there is a chance of contamination, clean and disinfect that place.
  42. 42. Equipment and raw materials •Equipment may be defined as a physical entity which is used to carry out a general or specific activity in the pharmaceutical plant. • It can be a single piece, for example compression, weighing machine. • Equipment is an integrated system that is, group of equipment come together to perform single activity. e.g.: water mineralizing plants, air handling systems. • Equipment is generally one of the major inputs along with people facilities, materials, and systems
  43. 43. •The quality of the manufactured product much depends on the suitability, and level of the technology of the equipment used since it is major requirement in the manufacture of the pharmaceutical products. • The regulatory literature on GMP in various countries gives enough importance and provide guide lines on the management of equipment in pharmaceutical plants. • we have a glance on international GMP literature following points coming up, those are: - Location and design - Preventive and breakdown maintenance - Construction - Size and adaptation - Cleaning and cross contamination - Installation and calibration - Qualification and validation - Automatic, mechanical, electronic equipment
  44. 44. Stages of equipment • Equipment management in the pharmaceutical industry has a life cycle, and the GMP requirement cover the life cycle of equipment. • It starts with decision to purchase equipment and ends with scrapping or elimination of equipment from operation. • Decision to purchase equipment is primarily need based. • It consists of following stages: - decision to purchase equipment - purchase of equipment - qualifying, installing and validating equipment - using the equipment
  45. 45. Selection of equipment 1. Availability of spares and servicing. 2. The frequency and ease of maintenance will significantly impact on productivity and even quality. 3.Equipment breakdown during processing could adversely affect quality. Included in the maintenance evaluation should be the cleanability of the equipment. 4.This will involve accessibility to the parts to be cleaned and the relative ease of disassembly and reassembly process. 5. Environmental issues are important constraints. Is the design of the equipment conductive to the application? Such attributes as the ability to contain toxic products, the ability to maintain aseptic conditions, etc. need to be reviewed.
  46. 46. 6. Construction materials and design. 7. The type of process controls such as automatic weight adjustment on tablet
  47. 47. Purchase specification Before we take decision to purchase an equipment we need to look many aspects. • This primarily helps the user requirement specification for the equipment. • Following questions may arise in relation to design, size, location, adaption and construction of the equipment. • Why the need arises for the purchase of equipment e.g. Creation of new facility, increasing capacity, Adapting to new and improved technology • Which operations we want perform with proposed equipment
  48. 48. • For example, equipment capability analysis, granulation, sterilization . • What capacity the equipment should have in terms output and holding? E.g. ten lakh tablets per shift or ten thousand litters of liquid. • How the equipment will be cleaned? And also need to consider that do we face any problem in validating the cleaning process of the equipment? •Do we have trained operators to operate this equipment? Or whether the manufacturer helps in training our existing operator. • What will be the starting and stopping time of the equipment?
  49. 49. Following factors are taken into consideration while purchasing the materials:- • Right source • Right quality • Right quantity • Right price • Right time • Right mode of transportation
  50. 50. WHO guidelines •Equipment must be located, designed, constructed, adapted and maintained to suit the operation to be carried out. • The layout and design of the equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination, buildup dust or dirt and in general any adverse effect on the quality of the product. • Equipment should be installed in such way as to minimize any risk of error or of contamination. • Production equipment should be designed, located, and maintained to serve its intended purpose.
  51. 51. • Production equipment should be designed, so that it can be easily and thoroughly cleaned on scheduled basis. • Production equipment should not present any hazard to the products. • The parts of the production equipment that come in to contact with the product must not be reactive ,additive or absorptive to an extent that would affect the quality of the product. • The equipment must designed to be compatible with most materials and process being used.
  52. 52. Equipment identification • Identification is one of the four quality attributes in the quality of pharmaceutical products. • The identity of equipment is also important along with the other identifications required just like, product, room, people, system. • Hence to meet this GMP requirement all equipment must be clearly identified.
  53. 53. Cleaning And Maintenance: • Use of cleaned equipment is one of the basic step in avoiding contamination and meeting the purity of the product. WHO guidelines: •The layout and design of the equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination build-up of dust or dirt. •Washing and cleaning equipment should be chosen and used so as to prevent source of contamination. • Defective equipment should, if possible be removed from production and quality control or at least clearly labeled as defective.
  54. 54. Raw materials All materials that used into the manufacturing of a finished bulk (even though it may not be present in final product e.g. Certain solvents etc.) and which are consumed by person using it are called as raw materials. Raw materials can be either active drug or inactive substances. eg. Hard gelatin capsules: even though it is used to fill the blend of medicine, it is not considered as package materials because it is consumed by person 3 using medicines.
  55. 55. Purchase specification • Written guidelines that precisely define the operational, physical, and/or chemical characteristics, as well as the quality and quantity of a particular item to be acquired. rawmaterial.doc • Mode of purchasing : • By inspection • By sample • By description of brand • By grading
  56. 56. Steps involved in purchase procedure 1. Purchase requisition 2. 2. Selection of supplies 3. Inviting Quotation 4. Placing the order 5. Receiving the material 6. Checking of invoice or bill 7. Recording of bills in books 8. Releasing the payment to the supplier
  57. 57. Staff involved in purchasing have a particular and thorough knowledge of products and suppliers. Raw material can be purchased from supplier named in relevant specification or directly from producer. Specification established by manufacturer for the starting materials be discussed with suppliers. Pharmacist or chemist, who is familiar with quality requirement of various material purchase department can be head of purchase department
  58. 58. Maintenance of stores Storage Area Specifications :- - Sufficient Capacity - Clean, Dry and Maintained within acceptable temp. limit - Designed and equipped reception area - Ensuring of quarantine status - Separate sampling area - Segregation for storage of rejected, recalled or returned material - Safe and secure area for narcotics and highly active, dangerous and risky material - First in First out rule (FIFO) - First expiring First Out (FEFO)
  59. 59. Storage conditions - Room temp. Should be 30° C and R. H. 60% - A.C storage (25± 2 ° C & R.H. 45 – 55%) - Low temp. storage 2 – 8 ° C - Separate area for Sterile product storage in A.C - Light sensitive material in amber color container - Hermitically sealed container - Labeling of material in storage area - Designated name of product and internal code reference - Batch no. given by supplier - Status of Content8 - Expiry date or date beyond which retesting is necessary
  60. 60. THANK YOU

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