| Department | Manufacturing | Document no | MAN-030 | ||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Document Owner
Operations Manager
Affected Parties
All manufacturing operations colleagues
Purpose
To outline the generation, maintenance and filing of Production logbooks.
Scope
Production logbooks form part of the documentation system required by the Code of GMP to provide complete and up-to-date histories of all batches of product.
The logbook provides a key link in the process of traceability.
This procedure is to be followed by all Manufacturing personnel.
Definition
| MI Sheet | Manufacturing Instruction Sheet |
Related Documents
| QMS-015 | Quality Documentation Management and Change Control |
| QMS-020 | Documentation Rule for GMP Documents |
| QMS-025 | Quality Documentation – Control, Tracking and Distribution |
| QMS-010 | All Documents – Classification, Definition and Approval Matrix |
EHS Statement
This procedure does not impact on Environment, Health and Safety.
Procedure
1. Background
Production Logbooks are used for a variety of reasons throughout the production area to aid with the recording of information relevant to machine operation or batch records.
Logbooks required are determined by GMP requirements for the traceability of data, events, and communications.
a) Each area must have:
Register Logbook recording, in sequence, all production batches processed in the area. The logbook is to be ruled up according to the template set out in point 4.
b) Finishing Line logbook.
These logbooks are an important source of information and must be retained for future reference.
The Team is responsible for the generation and proper maintenance of the logbook.
When a logbook has been filled, the Team should ensure that the logbooks are sent to the Quality assurance Department for logging in the Documentation Database as a quality file (refer SOP QMS-015).
Production logbooks are retained for a minimum of 15 years in the Technical File system. (See QMS-010)
3. Issuing and Labelling New Logbooks
The Team should issue the next logbook for the particular area through as consumable inventory. The logbook must be labelled on the front cover with the following information:
a. Team
b. Line name
c. Title of the logbook (i.e. Register, Communications)
d. Year
e. Date issued
All pages in the logbook are numbered sequentially.
No pages are to be removed from logbooks.
Correction to a logbook should follow the requirements of GMP and SOP QMS-020.
The Register Logbook is always to be ruled up according to the following format:
Other columns may be added e.g. Line Clearance, Line Opening.
Note: The layout is to be spread over 2 pages of the logbook:
| Date | Time Start | Product | Product
Code | BPN | Batch
Size | Container
Size | Line Cleaning
Date Time Sign | Comments | ||
Format should include date, time and initials of operator entering comments.
| Date/Time | Initials | Comments |
At the start of the shift, or at the start of a batch, operators are to enter their initials and work title into the table provided in the MI Sheet Logbook. The table format is as follows
a. Time/Date: Time date must be in the format hh.mm/dd.mm.yyyy
b. Initial: As registered
c. Work title: Is a free text field used to Indicate which area of the line operators are working on, including if they are in sterile (Where applicable).
If operators are attending the line to cover breaks, it is to be noted they were on the line by entering their name in the table in the logbooks MI sheet.
This applies to all tablet lines and is required for traceability purposes.
The Maintenance System is utilised to ensure, that if any work by maintenance staff is performed on the line, that the type of work, time and date will be recorded.
| Version # | Revision History |
| MAN-030 | New. |