Department | Quality Management | Document no | QMS-085 | ||
Title | Checklist for Batch Documentation | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Quality Assurance Manager
Affected Parties
All Operations and Quality Assurance colleagues
Purpose
To identify all documentation relevant to a Production process in the form of “Batch Documentation Checklists” and to ensure their collection by completion of the checklists by Authorized Persons.
Scope
An authorized production operator has to ensure all appropriate Batch (BPN) relevant records have been reviewed for completeness and included into the Batch Documentation.
Production operators have to print out the appropriate “Batch Documentation Checklist” Form for the Process being manufactured, complete the Production section of the Checklist and then include it into the top of the Batch Documentation. Process managers have to ensure an effective process of Batch Documentation collection.
QA staffs have to collect the batch documents and retention samples for QA Evaluation. Laboratory staffs have to collect the test samples for laboratory analysis.
Definition
Batch Documentation/Batch Document | All relevant paperwork for a particular batch, including samples of printed cartons, leaflet, shipper labels, Line Openings, Line Clearances records, etc. and collecting them together. |
Batch Number | Batch Production Number (BPN) |
Code Number | Material Number |
QA Inspection Sheet | It is a form printed by QA staff at the time of evaluating the batch documents to record pertinent data relevant to the BPN. |
Related Documents
Form-555 | Example-Batch Documentation Checklist for Tablet Packing |
QMS-090 | Example-Evaluation of Batch Documentation |
QMS-035 | Deviation Report System |
MAN-120 | Example-Packed Tablet Sampling by Production Personnel for Testing |
EHS Statement
This is a documentation procedure – there is no EHS impact.
Procedure
To be carried out by an Authorized Production Person (Operator)
1. At the Completion of the Batch
1.1. At the completion of a batch (BPN), authorized process operator has to print out a “Batch Documentation Checklist” (Form-555) relevant to the product (e.g. Tablets) manufactured. Check all the records and documents are attached including the all MI sheets relevant to the batch.
2. Evaluation of Batch Documentation by Production staff
2.1. All documents listed on the Batch Documentation Checklist must be evaluated and signed by an authorized production staff before they are sent to QA for evaluation. Each document should be reviewed and any issues resolved prior to collection by QA.
NOTE: The Quality Assurance Staff responsible for evaluating batch documents will raise a DR if any of the following deficiencies are noted during QA evaluation of the batch documents:
2.1.1. Critical entries have been left blank, e.g. missing signature on line clearance.
2.1.2. Excessive (i.e. greater than 5) non-critical entries are missing. (A production operator may correct non-critical entries, e.g. missing one tick, without raising of a DR by QA).
2.1.3. An entry is recorded incorrectly and not corrected, e.g. incorrect date.
2.1.4. Multiple (i.e. greater than 5) entries are marked as corrected by operators, as this indicates there has been an absence of due care.
2.1.5. Missing documentation, records or forms that cannot be recovered within 1 working day.
2.2. Authorized Process operator has to complete “Section 1 and 2” of the batch documentation checklist (Form-555). While completing the checklist, ensure that the correct documentation has been included into the Batch Documentation and that the documentation is complete and accurate.
NOTE: Batch documentation must be completed within 24 hours of booking out the last pallet for each batch.
2.3. Sample the batch samples in accordance with SOP MAN-120.
2.4. Documentation, which has not been identified on the specific checklists, must be returned to area Managers for assessment as to its relevance to be included into the Batch Documentation.
2.5. A Comment on the Batch Documentation Checklist must be made to indicate if extra documents are to be kept with the Batch Documents. (This comment is appropriate for Protocol purposes and to ensure Weight Check Sheets which are used for statistical purposes, are filed in the correct place.)
3. Flowchart – Batch Documentation
Summary of Changes
Version # | Revision History |
QMS-085 | New |
4. Appendix 1: Form-555: Example-Batch Documentation Checklist for Tablet Packing
a. Production is to complete Sections 1 & 2
b. Quality Assurance Department is to complete Section 3
SECTION 1
| PRODUCT NAME: | BPN: | CODE: |
Tick appropriate boxes | Yes |
Put a N/A against boxes which are NOT APPLICABLE | N/A |
SECTION 2
The following manufacturing documents and samples must accompany the checklist:
Production (yes) | ProdInitial | QA (yes) | |
MI Sheets for all the process phases | |||
Deviation Report Form (If any DR raised) | |||
Printed Material Sample Sheet/s | |||
Bulk Tablet Sampling Form/s (if applicable) | |||
Line Clearance, Opening and Cleaning Form/s | |||
Finished Good Retention Samples | |||
Material Transfer Order Form/s | |||
Vacuum Leak Test – Hourly Form | |||
Vacuum Leak Test – New Foil and PVC Roll Form | |||
In-Process Check – Shipper Form | |||
In-Process Check-Blister and Carton form | |||
Batch Reconciliation Sheet for Tablet Packing | |||
IBC Cleaning Tag/s | |||
IBC Identification Label/s | |||
Checkweigher Weight Record (if applicable) | |||
Pallet Booking Information |
If any deviation raised write the DR Number/s:(Attach the copy of deviation report/s) | ||
If any work-order raised during the batch write the order number/s: | ||
Name of authorized production person (print name): | ||
Signature of Authorized production person: | Date: | |
Comments: | ||
SECTION: 3
PRODUCT NAME: | CODE: | |||||||||
EXPIRY DATE: | BATCH (BPN) NO: | |||||||||
DEVIATION REPORT: | PROCESS LINE: | |||||||||
MANUFACTURING INSTRUCTION: | ||||||||||
All Phases Complete Checked (MI Sheet Status must be completed and Signed off) | Time / Date Blistering Finished | |||||||||
Time / Date Packing Started | ||||||||||
Expiry Date Checked | Time / Date Packing Finished | |||||||||
Incomplete Entries Checked | Carton % Yield Checked | |||||||||
MI Sheet Comments Checked | Leaflets % Yield Checked | |||||||||
Manufacturing Date (C of A) | / / | Label % Yield Checked | ||||||||
Time / Date Blistering Started | Tablet % Yield Checked | |||||||||
Retention Samples & Printed Materials Checked– Product Code, Description, BPN, Expiry Date, Pack Size, Temperature | ||||||||||
Shipper Label Checked – Product Code, Description, BPN, Expiry Date, Pack Size, Temperature, | ||||||||||
QUANTITYBatch Size: | Retention Samples:Stability Samples: | Packs to “Quarantine”: | ||||||||
Checklist Checked By | Print Name: | |||||||||
Signature: | Date: | |||||||||
Batch Document and QA Inspection Sheet Reviewed By | Initial: | Date: | ||||||||
Name of Authorized QA Person(Print Name): | ||||||||||