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A SEMINAR ON GMP - EQUIPMENT:

A SEMINAR ON GMP - EQUIPMENT 1 Prepared By: Nayan Jagani M. Pharm Sem-1 Q.A . Department Guided by: Mr. Jignesh S. Shah S. J. Thakkar Pharmacy College - Rajkot.

OVER VIEW FOR EQUIPMENT:

OVER VIEW FOR EQUIPMENT Introduction Equipment selection Equipment design, size and location Equipment construction Equipment identification Cleaning and maintenance Automated, mechanical and electronic equipment Filter Weighing balance Purchase specification SOP 2

Introduction:

Introduction Equipment may be defined as a physical entity which is used to carry out a general or specific activity in the plant. Equipment is the major inputs in the manufacture of the pharmaceutical products, in the regulatory literature on GMP in various countries gives the importance & hence provide guidelines on the management of equipment in pharmaceutical plants. Equipment may be : Single system or piece, Integrated system. 3

Equipment Selection:

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 Operating criteria, Availability of spares and servicing Maintenance, Environmental issues, Availability of design & maintenance manuals, Cost. 4

Equipment design, size and location:

Equipment design, size and location Equipment used in the manufacture, processing, packing or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use. Availability of design and maintenance manuals from the supplier that are important for validation/qualification and maintenance programs. Equipment suitably located & designed for easy cleaning and maintenance. 5

Equipment construction:

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. 6

Equipment Identification:

Equipment Identification 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. 7

Cleaning And Maintenance :

Cleaning And Maintenance Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent contamination. Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. A cleaning procedure desired at end of working shift only for equipment in which a wet processing stage has been carried out. Cleaning and washing may be : Manual Automated -CIP , -SIP 8

cleaning validation:-:

cleaning validation:- why it is important? Essential to establish adequate cleaning procedures. Cleaning validation should be performed in order to confirm the effectiveness of a cleaning procedure. The data should support a conclusion that residues have been reduced to an ‘acceptable’ level. sampling methods: Swab sampling, Rinse fluid, Placebo flush, Visual Examination. Analytical method: HPLC, GC, HPTLC, pH , Conductivity, UV, ELISA. 9

Slide 10:

Every equipment must have SOP’s for operation, cleaning and maintenance. There may be system to distinguish equipment in three categories: Operational equipment ( with green card ), Equipment under maintenance ( yellow card ), Defective equipment (red card ). The operator doing cleaning and maintenance must be so trained that their activities of cleaning and maintenance will not affect or contaminate product. Records of all activities on equipment must be chronologically recorded in the equipment log book. 10

Types of Maintenance:

Types of Maintenance 11 Equipment Maintenance : defined as facilities maintain to some desired level of efficiency to keep assets in a satisfactory condition.

Slide 12:

12 Breakdown maintenance:- It means that people waits until equipment fails and repair it. Such a thing could be used when the equipment failure does not significantly affect the operation or production or generate any significant loss other than repair cost. Corrective maintenance ( 1957 ):- It improves equipment and its components so that preventive maintenance can be carried out reliably. Equipment with design weakness must be redesigned to improve reliability or improving maintainability . Maintenance prevention ( 1960 ):- It indicates the design of a new equipment. Weakness of current machines are sufficiently studied and are incorporated before commissioning a new equipment.

Slide 13:

13 Preventive maintenance ( 1951 ) :- It is a daily maintenance ( cleaning, inspection, oiling and re-tightening ), design to retain the healthy condition of equipment and prevent failure through the prevention of deterioration, periodic inspection or equipment condition diagnosis, to measure deterioration. It is further divided into periodic maintenance and predictive maintenance. Periodic maintenance ( Time based maintenance - TBM) : Time based maintenance consists of periodically inspecting, servicing and cleaning equipment and replacing parts to prevent sudden failure and process problems. Predictive maintenance :- This is a method in which the service life of important part is predicted based on inspection or diagnosis, in order to use the parts to the limit of their service life. Compared to periodic maintenance, predictive maintenance is condition based maintenance.

SOP on cleaning, operation and maintenance:

SOP on cleaning, operation and maintenance Name of equipment and its unique identification no. Responsible person to carry out and supervise operation schedule maintenance and cleaning. Material use for cleaning and its complete removal after cleaning. Removal of previous batch identification. Protection of cleaned equipment. Inspection of cleaned equipment. Detailed step by step operation of equipment. Detailed step by step prcedure to carry out prevententive maintenance. Record of cleanig, maintenance and operation. 14

Equipment cleaning & maintenance record:

Department : Month: Equipment: Make: Equipment identification No.: Working Capacity: Cleaning sop no. : Maintenance sop no.: Cleaning Maintenance Date Sign Remark Date Sign Remark Equipment cleaning & maintenance record 15

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INDIAN PHARMACEUTICAL LTD. Daily maintenance record sheet Sr. no. Department Work performed Time Part replaced Starting completion Date:________ Work left for next day:______________________________________ ________________________________________________________ Remark:_________________________________________________ Work performed by Inspected by Deptt. Head ________________________________________________________ ________________________________________________________ 16

INDIAN PHARMACEUTICAL LTD. Machine breakdown card:

INDIAN PHARMACEUTICAL LTD. Machine breakdown card Name Of Machine: Room No.: Identification No.: Department: 17 Sr. No. Date Time Type of breakdown Maintenance work performed Time Sign Part Name/Part No. Replace From To

USP divides the equipment into three groups based on respective complexity :

USP divides the equipment into three groups based on respective complexity Group A Group B Group C E.g. stirrer E.g. pH meter, balance E.g. HPLC,GC They are simplest. Only visual observation is needed to confirm that it is qualified. Little complex. Written procedure must be followed. Though testing of their qualification is generally straightforward and identifiable. Highest complex. Deep n complete literature must be provided. 18

Slide 19:

AIQ (ANALYTICAL INSTRUMENT QUALIFICATION) DQ (DESIGN QUALIFICATION) IQ (INSTALLATION QUALIFICATION) OQ (OPERATIONAL QUALIFICATION) PQ (PERFORMANCE QUALIFICATION) There are four qualification phases are also described by the WHO's Good Manufacturing Practices Guide for Quality Assurance of Pharmaceuticals. 19

Slide 20:

These types of equipment includes computers or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. It should be routinely calibrated, inspected or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained. 20 AUTOMATIC, MECHANICALAND ELECTRONIC EQUIPMENT

Slide 21:

Appropriate controls shall be exercised over computer or related system to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. 21

Filters:

Filters Filter used as a part of equipment & Filtration is one of the processes use in pharmaceutical operation and air systems. Filter for liquid filtration used in the manufacture, processing or packing of injectable drug products intended for human use shall not release fiber into products. As a part of GMP, filters should be considered from following: Type of filter and filration process, Compatibility of filter media with processing material, Cleaning of reusable filter and their sanitization, validation of filter, Disposal of filter. 22

Slide 23:

INDIAN PHARMACEUTICAL LTD. Pre-air filter record Sr. no. location Cleaning date Clean by Manometer reading before Manometer reading after washing Remark water Air 1 2 3 4 5 Name of filter: Size: Pore size: 23

Weighing balance:

Weighing balance Balance and other measuring equipment of appropriate range and precision should be available for production and control operation. Measuring, weighing, recording and control equipment should be calibrated & checked at defined interval by appropriate method. Adequate record of such tests should be maintained. All weighing balance should be in a state of calibration. The name, signature and date of person weighing and supervising weighing operations must be recorded. A list of various weighing balance should be made with following: Description of balance , Model number, Weighing range, location, Frequency of calibration. 24

Purchase specification of equipment:

Purchase specification of equipment Definition:- Detailed description of the measurable characteristics desired in an equipment to be purchased such as quality, size, weight , performance parameters, safety requirements etc. The documents used for the procurement of equipment should consist: User Requirement Specification Relevant Standard Demand Specifications, and Purchase Agreement. 25

Purchase specification of UV-VIS Spectrophotometer, double beam:

Purchase specification of UV-VIS Spectrophotometer, double beam Wavelength : 190-900 nm or more Optical System : Double beam with double monochromator Light Source : D2 and Tungsten Wavelength accuracy : +/- 0.1 nm Spectral Bandwidth : at least, 0.5, 1, 2, 5 (variable) Photometric Range : at least -0.3~3 Abs Photometric Modes : Abs,%T Stray Light minimum Wavelength Scan Speed : 800-10 nm/min Baseline Stability : +/-0.0008Abs/Hour or less Detector : Photomultiplier R928 Control : By Computer Quartz Cuvette Branded Computer monitor with latest specification Laser Printer D2 Lamp, tungsten Lamp 5 years maintenance of the system 26

Purchase specification of water bath :

Purchase specification of water bath 10 L to 15 L water tank volume Water circulation to maintain uniform temperature Working temperature : ambient +5˚C to 100˚C or more Stability : ±0.1˚C or less Increment : ±1˚C or less Microprocessor control for precise temperature Over-temperature cut-off Audible and visible alarms LED display with 0.1˚C resolution for temperature Operable at 220 volts 5 year equipment maintenance 27

SOP for Equipment:

SOP for Equipment Definition : A written authorized procedure which gives instructions for performing operations necessarily specific to a given equipment. What are SOPs ? They are the tools to ensure that GMP is being followed wherever applicable. It contains relevant information about any activity or process carried out (like calibration validation , maintenances , cleaning , production , packing or even for receipt or movement of raw material ). Why SOPs are needed? Due to demand of safe and efficacious drug product in the market. In addition to clinical factors storage , handling of raw material and final product , cross contamination and batch to batch deviation affects the quality of product. We don’t want any loss or refusal. 28

Slide 29:

29 Precautions for preparing SOPs:- Information & procedures in clear and unambiguous language and specifications for the facilities should be provided. By following SOPs the quality product should be expected. Significant deviations are recorded and investigated. Documents must not be changed or added or reviewed or amended without any authorization. Easy to retrieve from master SOP and check also critical steps should be highlighted. Must not allow any error. Regularly updated and previous suspended SOPs are preserved for at least 1 year after the last batch made on it has been expired. Original copy is kept in locker and one copy is displayed in all the concern areas and retained with each member who has signed in it.

Slide 30:

GOOD QUALITY PHARMACEUTICALS PVT. LTD. STANDARD OPERATING PROCEDURE Name of equipment:- Model No.:- Purpose:- Scope:- Responsibility:- Procedure:- Prepared By (GM Production) Checked By (QC Manager) Authorized By ( DirectorTechnical ) 30 Department : Procedure no.: Page no. : _ to_ Effective Date : Superceeds earlier procedure date : Review date :

Slide 31:

VARIOUS DOCUMENT 31

INDIAN PHARMACEUTICALS LTD. List of equipment:

INDIAN PHARMACEUTICALS LTD. List of equipment Sr. No. Name of Equipment Capacity Output/Holding Make Date Of Installation Material of Construction 32

Slide 33:

Laboratory Master File of Instruments Instrument Name Manufacturer Maintenance Frequency Service & Repair conducted by: Calibration Frequency Calibration procedure 33

Reference::

Reference: C- Gmp for pharmaceutical by Manohar A. Potdar Quality Manual, by D. H. Shah Good Manufacturing Practices for Pharmaceuticals, vol. 109 , Marcel Dekkar Inc., N. Y. www.wikipedia.com www.pharmaquality.com 34

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THANK YOU! 35