SOP for Preparation of Site Master File (SMF)
1.0 OBJECTIVE:
To lay down the procedure for preparation of Site Master File (SMF).
2.0 SCOPE:
This standard Operating Procedure (SOP) applies for the preparation of Site Master File covering the intent to provide a road map for GMP information about the production and /or control of pharmaceutical manufacturing operation carried out at [company name] and any closely integrated operation at adjacent and near by buildings.
3.0 RESPONSIBILITY:
QA Personnel : To prepare the Site Master File.
All HOD: To give inputs if any in preparation of Site Master File.
Head QA: To Approve the Site Master File. To Approve Addendum / Changes observed periodically.
Unit Head: To Approve the Site Master File.
4.0 PROCEDURE:
The content of Site Master File shall include but not limited to following:
4.1 General Information: This section shall give the details under following headings.
4.1.1 [Company name]’s Profile:
This section shall give the brief detail information on the organization describing the regulatory credential available at each location along with other related information.
4.1.2 Manufacturing Activities:
This section shall give the brief detail information on the nature or type of Dosage forms manufactured at the site. Example Oral or Parenteral formulation or any other. Details of pharmaceutical manufacturing activities as licensed by the national authority.
4.1.3 Other Manufacturing activities carried out at the site:
This section shall give the details regarding any other manufacturing activities carried out at the site.
4.1.4 Name and address of manufacturing site and Head Office:
This section shall give the Name and exact address of site, including telephone numbers, fax numbers, and 24 hours telephone number or out of hours contact number.
4.1.5 Types of product manufactured:
This section will give details regarding type of product manufactured at the site, and information about any specifically toxic or hazardous substances handled, mentioning the way they are manufactured in dedicated facilities or on a campaign basis (if any).
4.1.6 Description of the site:
This section shall give the details regarding the Location of the site, details of the surrounding environment, manufacturing capacity on two sift basis, and information on size of the different section in square meters & other relevant information.
4.1.7 No. of employees at [Company name]:
This section shall give details regarding the number of employees working in the following department like production, Quality Control, Quality Assurance, Engineering and Administration.
4.1.8 Use of outside scientific, Analytical or Technical Assistance:
This section shall give details regarding the external contract laboratory for analytical and Technical assistance in relation to manufacture and analysis. This shall include the Address, Phone number, Fax, Mail ID of outside parties.
4.1.9 Quality Management system (QMS):
This section shall give the details regarding the quality management system applicable and followed by manufacturing site. This will briefly describe the Quality policy of the [Company name]. This section shall also include the responsibility of various Quality functions describing the role of Corporate Quality Assurance (CQA) and Location Quality Assurance. Details regarding elements of Quality system, Audit programs, Annual product review, Quality Manual, Vendor approval system.
4.2 Personnel:
This section shall give the details under following headings.
4.2.1 Organogram of [Company]:
This section shall give the details regarding the organization chart showing arrangements for quality assurance, including production, quality control and other department.
4.2.2 Details of Key personnel:
This section shall give details regarding key personnel’s including their Name, Qualification, Total Experience, Designation and responsibility.
4.2.3 Training:
This section shall give details regarding arrangements of basic training modules available at the site. This section shall give details how various training such as Induction training, On job training and cGMP training conducted. This also specifies the training needs to be identified for the plant personnel. This covers the Information on Management of training records.
4.2.4 Health requirement for personnel engaged in production:
This section shall specify minimum health requirements for the personnel working in the production area. This part shall specify or enlist the type of test carried out during Annual Medical Check Up.
4.2.5 Personnel hygiene requirement and clothing:
This section shall give the details like training on personnel hygiene to all employees. This part also gives the information about dress codes for employees in various departments.
4.3 Premises and Equipment:
This section shall give the details under following headings.
4.3.1 Description of manufacturing area:
This section shall give information / description of manufacturing area with indication of scale. Area in square meters and other relevant information.
4.3.2 Nature of construction and finishes:
This section shall give the information of material of construction related to the manufacturing building including walls, flooring, ceilings, supply of utilities for equipment running. Other facility if provided for preventing any cross contamination.
4.3.3 HVAC system:
This section shall give the brief details regarding types of ventilation system available at the site. It also define the purpose as to why the ventilation system is required. It includes the details of various sequence of filters used in system. Information of various tests to be performed at desired frequency to qualify the system.
4.3.4 Highly toxic and Hazardous material handled at site:
This section shall give the brief description on handling of highly toxic, hazardous and sensitizing materials at the site (if any).
4.3.5 Description of water system:
This section shall give the brief description of water system available at the site. Details regarding the purified water generation system, filtration system, sanitization of loop system, Temperature range for purified water in loop system.
4.3.6 Preventive maintenance system for Equipment / instruments / system:
This section shall give the brief description of preventive maintenance program for equipment / instruments in production, utilities and other area. It also gives information related to documentation procedure for recording Breakdown of machine and replacement of any components / part of the equipment / instruments.
4.3.7 Description of major Equipment in production, quality control laboratory:
This section shall give the list of major equipment used in manufacturing of the drug product and instruments, used in analysis of the product/ materials available at the site. It also gives the description regarding the qualification status of the equipment/ instruments and details regarding the design of the equipment used in the manufacturing of the product.
4.3.8 cGMP related computerized system:
This section shall give the information on the various system software’s available and practiced at the site such as LIMS, Materiel Management System etc. This also includes information on the Programmable Logic Controller (PLC) system validation.
4.3.9 Qualification, Validation and Calibration:
This section shall give the details regarding the Qualification, validation, and calibration policy for equipment/ instruments at the site. This also gives the details regarding the validation status for product manufactured at the site.
4.3.10 Sanitization:
This section shall give the details regarding the sanitization practice followed in the premises, manufacturing area, water plant and other relevant areas. This is performed as per the written procedure, at scheduled frequency.
4.4 Documentation:
This section shall give the details under following headings.
4.4.1 General Documentation system:
This section shall gives information on documentation for all the activities starting from the receipt of materials to conversion into finished goods and transfer to Bonded Store Room (BSR). It includes the information related to documents received from Corporate Quality Assurance (CQA). This part also gives information regarding handling of various documents like SOP’s, OOS, Market complaints, Deviation, Incidents, Self-inspection, and other relevant information related to documentation practices.
4.5 Production:
This section shall give the details under following headings.
4.5.1 Description of manufacturing operation:
This section shall give information regarding vendor of starting materials, various labeling system used in production areas and other relevant information like packaging material, Finished product, quarantine, release procedure, and storage.
4.5.2 Starting Material and Packing Material:
This section shall give brief description regarding Raw material and Packing Material, including Secondary packing material. Their segregation and quarantining of materials. Traceability of the related documentation.
4.5.3 Handling of rejected materials:
This section shall give information regarding storage condition of rejected material (Raw materials and Packaging materials) and Finished products, and their destruction procedure.
4.5.4 General policy for process validation:
This section shall give brief information on process validation activity performed at the site. This also specifies the criteria for performing the process validation activity. This section describes the brief methodology for performing the activity.
4.6 Quality Control:
This section shall give the information on different aspects in quality control department at the site. This shall include information about the Raw material and finished product section. This give the information on testing of the material / product, review of the documents, and then release from the system after final approval.
4.7 Contract manufacturing and analysis:
This section shall give details regarding the external contract laboratory for analytical and Technical assistance in relation to manufacture and analysis. This shall include the Address, Phone number, Fax, Mail ID of outside parties.
4.8 Distribution, Complaints and Product recalls: This section shall give the details under following headings.
4.8.1 Distribution practices:
This section shall give the details regarding the storage condition of the finished goods at the site, temperature condition required, stacking of goods, labeling for easy identification, and other dispatch details.
4.8.2 Record of Distribution:
This section shall give the procedure for full traceability to track the goods dispatched and quantity dispatched.
4.8.3 Handling of Market complaints: This section shall give the procedure for handling the market complaints, categorization of complaints and closing of the same.
4.8.4 Product Recalls:
This section shall give the procedure for calling urgent product recall in defined cases, investigation of the product, reconciliation of the goods, medium of giving information to the concern people and procedure for evaluating the effectiveness of recall.
4.9 Self Inspection:
4.9.1 This section shall give the short description on the self-inspection system practiced at the site. It gives the procedure for identifying the non-compliance and verifying the compliance within the decided target completion date.
4.10 Site Master File shall include the list of various attachments and drawings (if available) in conjunction with the relevant systems.
4.11 Based on the above-mentioned index, guidance the preparation of Site Master File shall be preceded.
4.12 Any changes in the Site Master File shall be addressed by preparation of Addendum (If the changes are Significant) or in the subsequent revision.
5.0 ANNEXURE (S):
Nil