standard operating procedure machine history file
1.0 PURPOSE
To define a procedure for maintaining history in case of any minor/major changes/modifications done in the critical Machines.
2.0 SCOPE
2.1 This procedure applies to all critical machine used for various stages of dispensing, manufacturing and packing of formulations and machines used for supply of utility services for production activities
3.0 Abbreviations
3.0.1 No. : Number
3.2.1 EHS : Environment, Health and Safety
3.2.2 SOP : Standard Operating Procedures
4.0 RESPONSIBILITY:
4.1 User Department:
4.1.1 To fill and maintain the Machine history file.
4.2 Quality Assurance Head:
4.2.1 To ensure implementation of the defined procedure.
4.3 Plant Head:
4.3.1 To ensure implementation of the defined procedure.
5.0 Distribution:
I. Quality Assurance
II. Quality Control
III. Production
IV. Ware house
V. Engineering
6.0 PROCEDURE:
6.1 After installation and subsequent handover of the machine for regular use, the ‘Machine History file’ shall be maintained with details of any minor/major changes/modifications with reason as per Attachment-I.
6.2 The changes made shall be recorded whenever changes or modifications are carried out.
6.3 On completion of minor/major changes/modifications the machine shall be cleaned as per respective machine cleaning (product changeover cleaning if applicable) SOP.
6.4 Machine shall be certified by Production, Engineering, EHS and Quality Assurance department for proper setting and operation to get zero defect before use of machine for Production activities.
6.5 After rectification of all critical and major breakdowns, the machine shall be re-qualified as per SOP “Qualification of Equipment”.
7.0 References
7.0.1 SOP : Qualification of Equipment
8.1 Attachments
8.1.1 Attachment- I: Machine History file
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