Preparation of Site Master File

 

 

Preparation of Site Master File

 

1.0 OBJECTIVE :
1.1 To lay down a procedure for preparation of Site Master File.

2.0 SCOPE :
2.1 This procedure is applicable for preparation of Site Master File at ABC pharma Private Limited Roorkee.

3.0 RESPONSIBILITY :
3.1 Officer / Executive QA or designee shall be responsible for:
3.2 Preparation, Controlling, distributing and withdrawal of this SOP.
3.3 Executive/Manager QA shall be responsible for review and revision of this SOP.
3.4 Head QA or designee shall be responsible for approval of this SOP Director / Plant Head is responsible for authorization of this SOP.
3.5 Head QA or designee shall be responsible for ensuring that this SOP is implemented as per laid down
procedure.



4.0 ACCOUNTABILITY :
4.1 Head QA.

5.0 PROCEDURE :
5.1 The SMF shall be prepared with the header mentioned below

 

5.3 Second page of SMF shall have table of content as mentioned below.

INDEX

            Sr. No. Description Page No.
NA Approval
1.0 General Information
2.0 Personnel
3.0 Premises
4.0 Equipment
5.0 Cleaning & Sanitation
6.0 Documentation
7.0 Production
8.0 Quality Control & Quality Assurance
9.0 Contract Manufacturing & Analysis
10.0 Distribution, Compliant & Product Recall
11.0 Self-Inspection
12.0 List of Export Countries
13.0 List of Annexures




5.4 Numbering of the SMF shall be done as follow
5.4.1 For example XXXX/YYY/ZZZ
5.4.2 XXXX = Stands for “ ABC ” which represent  ABC  Pharma Pvt. Ltd.
5.4.3 YYY = Stands for “ SMF ” that is Site Master File.
5.4.4 ZZZ = Stands for version number of SMF which starts with 000 and ends at 999. When the SMF is prepared for the first time, this number starts with 000 and at every revision it will be added up with one number.
5.5 Revision of the SMF shall be done in the following case
5.5.1 Revision of the SMF shall be done in two year routinely.
5.5.2 Revision of the SMF shall be done as per regulatory requirement.
5.6 Revision of the Annexures shall be done in the following case
5.6.1 Revision of the Annexure shall be done when there is change in layouts, organograms, key personnel
5.6.2 Revision of the Annexure shall be done when addition of new product, Equipments /Instrument ID etc.

 

6.0 ABBREVIATION :

Sr. No. Abbreviation used Full form of abbreviation used
1.0 SOP Standard Operating Procedure
2.0 SMF Site Master File
3.0 QA Quality Assurance

7.0 ATTACHMENTS (ANNEXES) :
Annex : Nil

8.0 REFERENCE :

Sr. No. Reference Title
1 PIC/S -Explanatory Notes for  Pharmaceutical manufacturers on the preparation of  a site master file

preparation for sampling Intimation slip

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel

SOP FOR BATCH MANUFACTURING

sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area

Preparation of Site Master File

 

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