Preparation of Site Master File – SOP

By / Quality Assurance / QA, SOP /

SOP for Site Master File | Site Master File of Pharma Company |

  • Site Master File SOP covers below points:
    • Site Master File General Information
    • Site Master File include below information
      • Personnel
      • Premises
      • Equipment
      • Documentation
      • Production
      • Quality Control
      • Contract Manufacture & analysis
      • Distribution, Complaints & Product Recall
      • Self-Inspection
1.0 OBJECTIVE :
  • This SOP defines the procedure for the preparation of Site Master File.
2.0 SCOPE :
  • This procedure is applicable to preparation of Site Master File of Company.
3.0 RESPONSIBILITY :
  • Quality Assurance Head
  • Plant Head
4.0 ACCOUNTABILITY:
  • Q.A. Head
5.0 PROCEDURE :

5.1 Prepare Site master file containing specific information about the quality management policies, activities of the site like the production & quality control of the pharmaceutical manufacturing operations carried out at the site & any closely integrated operations at adjacent & nearby buildings.

5.2 Review and update site master file within six months in case change in layout or other major modification. Else review period is 24 months.

5.3 Prepare Site Master File in standard format on A4 white paper as per attached format.

5.4 Restrict number of pages in Site Master File to maximum of 25 pages excluding annexures.

5.5 Make original copy as master and use control copy for other purposes.

5.6 Cover following information in Site Master File, as follows.

5.7 General Information :

  • Brief information on the Firm : It should includes the Name & Address of the site with information regarding the neighboring industries.
  • Pharmaceutical manufacturing activities as licensed by the national authority: It should Include the valid manufacturing license issued by local Food and Drug Administration (FDA) with the pharmaceutical dosage Forms manufactured at the site.
  • Any other manufacturing activities carried out on the site: It should include the details of The manufacturing activities other than the manufacturing of pharmaceutical dosage form.
  • Name & exact address of the site, including the telephone, fax & 24 hours telephone numbers: It should includes Company Name with Plant & Register Office Address with respective Telephone No., Fax No. & Email & the Contact person’s Name, their Residential Address & phone numbers or Mobile numbers for the emergency.
  • Type of the products manufactured on the site & information about any specifically toxic or hazardous substances handled, mentioning the way they are manufactured: It should include the details of the products manufactured at the site.  If the Toxic or hazardous substance is required for manufacturing then the details of the handling should be provided.
  • Short description of the site : It should include the size, location & immediate environment on the site. The short description of the site includes Management & administration of the building, Various departments position, Utilities Position & Material & Men flow or movement.
  • Number of Employee & workers engaged in : It should include the details of the Staff & Workers engaged in individual department.
  • Use of outside scientific, analytical or other technical assistance in relation to Manufacturer & analysis: It should include the Public testing laboratories approved by Local FDA which is to be hired by the site for the analysis on Sophisticated Instruments.
  • Short description of the Quality management (QM) system of the firm responsible for manufacture: It should include the brief description of the Quality policy of the company. It also includes the responsibility of the Head of the Quality management to conduct Internal audit & Review the reports & carry out the compliance from respective department, Vendor approval for both raw material & for packing material, Finished Product batch release & document control etc.

5.8 Personnel :

  • Organization Chart : It should include the flow of responsibilities for Quality Assurance, Quality control, Production, Warehouse, Engineering & Human Resources also their reporting to management.
  • Qualification, Experience & responsibilities of key personnel : It should includes the responsibility of the key persons of the organization.
  • Outline of arrangements for basic & in-service training & how records are maintained : It should include the organization plan of identified the training needs, in particular GMP introduction & reinforcement / upgrading job related skills, in-house & external training etc. Also the Evaluation of the training is to be carried out to check the training effectiveness.
  • Health requirements for personal engaged in production : It should include the medical examination of the employee prior to & during employment.
  • Personal hygiene requirements, including clothing : It should includes the company policy regarding the Factory Uniform & footwear, cleanliness, change room procedures, & the rules regarding the eating, drinking, smoking, chewing tobacco etc. in the factory premises

5.9 Premises :

  • Simple plan or description of manufacturing areas with indication of scale : It should Include the layout of the plant with the man & material movement or flow diagram.
  • Nature of the construction & finishes : It should includes the description of the wall construction, nature of the finishes, floors, ceilings, doors & windows, lighting, piping & drainage system.
  • Brief description of Ventilation System : It should includes the details of Heating Ventilation and Air Conditioning (HVAC) system with the more details should be given for critical area. Different classes of air, pressure differential principles to prevent cross-contamination, dedicated air handling units, forced ventilation system etc. are covered. Also attach the classified areas schematic drawing of the systems of the lay out the plant.
  • Brief description of Water system : It should include the brief description of the water System like source of Raw water, Storage tanks, Preparation of Purified water & its distribution System with make, Capacity/day & sanitation procedures.
  • Description of planned preventive maintenance program for premises & of the Recording System : It should includes the critical activities of the annual planned preventive Maintenance program for the premises.

5.10 Equipment :

  • Description of the planned preventive maintenance programs for equipment & of the Recording system : It should includes the written program for the planned preventive maintenance of the Equipments along with the frequency & checklist for each & every Equipment.
  • Qualification & calibration, including the recording system: It should includes the Validation Master Plan (VMP) details which covers the qualification, Calibration & revalidation policy of the organization. The cleaning validation schedule & annual plans also included.

5.11 Documentation :

  • Arrangement for the preparation, revision & distribution of necessary documentation for manufacture : It should includes preparation, distribution, retrieval, review, storage & destruction of the documents which are used in the manufacturing like Master Formula Record, Batch Manufacturing Record, Batch Packing Record and Operating Procedures etc.
  • Any other documentation related to product quality that is not mentioned elsewhere : It Should includes preparation, distribution, retrieval, review, storage & destruction of the Documents which are related to product quality like Raw Material, Packing  Material, In-process & Finished Goods specification, Quality Control analytical reports, Validation protocols & reports, Instrument / Equipment Log Books, Reference Standard /Working Standard records, Operation & Calibration SOPs, Specifications required for testing of Air & Water for microbiological growth & its records etc.

5.12 Production :

  • Brief description of production operations using, wherever possible flow sheets & charts specifying important parameters : It should includes the general steps required for the manufacturing of the pharmaceutical product including packing & indicating the equipment & critical in-process control parameters regularly measured.
  • Arrangement for the handling of the starting materials, packaging material & bulk & finished products including the sampling, quarantine, release & storage : It should includes the procedure for the Vendor Approval, Receiving, Sampling, Release & Rejection of RM/PM. It also includes the procedure like material requisition procedure from production to warehouse & dispensing of the material & transfer of the same from warehouse to manufacturing area, manufacturing of the products, sampling of FG, quarantine, release & storage.
  • Brief description of general policy for process validation: It should includes the reference of Validation Master Plan which includes the procedure for Analytical methods validation & for process validation.

5.13 Quality Control :

  • Description of the Quality control System & of the activities of the Quality Control Department : It should includes the detail procedure for the testing of starting material, in-process material, bulk & finished goods as per validated & approved analytical test methods, Release & rejection of the same & to maintain the analytical reports of the same. It also include the calibration & validation program related to QC Instruments/ Equipments, Starting Material & Finished Goods & the documentation related to Quality Control department.

5.14 Contract Manufacture & analysis :

  • It should include the details of the contract manufacture products & their testing.

5.15 Distribution, Complaints & Product Recall :

  • Arrangements & recording systems for distribution : It should include the records of the distribution including the wholesalers & directly supplied customers in case of export for the effective recall.
  • Arrangement for the handling of the complaints & product recalls : It should include the Detail procedure to handle the market complaint & its investigation & the action plan if in case there is a product recall.

5.16 Self-Inspection :

  • Short description of the Self-inspection system : It should include the procedure for self inspection, its frequency, review , its reporting to management & Compliance.
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
Q.A.Quality Assurance
cGLPCurrent Good Laboratories Practice
GMPGood Manufacturing Practice

7.0 ANNEXURES:
Annexure No.Title
01Format for Site Master File

8.0 SOP REFERENCES
  • WHO Guideline
  • Drugs and cosmetic Act and Rule 1945

END OF THE SOP

ANNEXURES :

Annex. No. 01 Format for Site Master File