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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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