Good Manufacturing Practices (GMP) Checklist | Manufacturing Templates

Personnel & Training

1 of 10

Focuses on the qualifications, training, and hygiene of personnel involved in the manufacturing process.

Number of Qualified Personnel

Training Records Maintained?

Yes

N/A

Last GMP Training Completion Date (Employee 1)

Brief Description of Training Program Content

Personnel Hygiene Practices Observed?

Yes

N/A

Personnel Training Records (Sample)

Specific Training Areas Covered (Select All That Apply)

Data Integrity

Equipment Operation

Personal Hygiene

Process Validation

Good Documentation Practices

Name of Designated Training Coordinator

Premises & Equipment

2 of 10

Addresses the cleanliness, maintenance, and suitability of the manufacturing facility and equipment.

Ambient Temperature (Manufacturing Area)

Relative Humidity (Manufacturing Area)

Description of any pest control measures taken

Floor Material Adequacy

Appropriate and Cleanable

Needs Improvement

Unacceptable

Lighting Adequacy

Adequate for Operations

Insufficient

Needs Adjustment

Photographs of Equipment and Facility

Last Equipment Cleaning Date

Description of any identified deficiencies

Documentation & Records

3 of 10

Covers the systems and procedures for documenting all aspects of the manufacturing process.

Document Creation Date

Document Revision Number

Document Purpose and Scope

SOP Document (e.g., Manufacturing Instructions)

Document Status (Approved/Reviewed/Obsolete)

Approved

Reviewed

Obsolete

Document Review Date

Prepared By (Name & Position)

Signature of Document Author

Raw Materials & Components

4 of 10

Covers receipt, storage, testing, and handling of raw materials and components.

Batch Number of Received Material

Date of Receipt

Supplier Approval Status

Approved

Pending Approval

Not Approved

Quantity Received

Quantity Accepted

Remarks/Observations during Receipt

Certificate of Analysis (CoA) Received?

Yes

CoA File Upload (if applicable)

Material Quarantine Status

Quarantined

Released

Manufacturing Process Controls

5 of 10

Details procedures to ensure consistent production and quality of the product.

Batch Size Confirmed?

Process Step Adherence

Fully Adhered

Minor Deviation

Significant Deviation

Process Parameter Monitoring Details

Temperature During Reaction (ºC)

Reaction Completion Time

Any Process Anomalies Observed?

In-Process Testing Conducted?

Yes

In-Process Testing Results (if applicable)

Packaging & Labeling

6 of 10

Covers the processes and controls related to packaging and labeling of the manufactured product.

Packaging Material Approved?

Yes

N/A

Packaging Material Specification Number:

Number of Packaging Components Verified:

Details of any discrepancies found in packaging:

Packaging Label Approval Document:

Label Information Verified against Master Record?

Yes

N/A

Label Elements Verified (Check all that apply):

Product Name

Batch Number

Expiry Date

Dosage/Strength

Warnings

Storage Conditions

Manufacturer Information

Label Sequence Number:

Cleaning & Sanitation

7 of 10

Focuses on procedures to maintain cleanliness and prevent contamination throughout the facility.

Cleaning Procedure Documentation

Cleaning Agents Used (Specify all)

Detergent

Sanitizer (Specify type: ________)

Disinfectant (Specify type: ________)

Other (Specify: ________)

Concentration of Cleaning Agents (%, ppm, etc.)

Date of Last Cleaning of Equipment/Area [Equipment ID/Area Name]

Details of any unusual cleaning procedures required for specific equipment/areas.

Cleaning Validation Status (For Critical Equipment/Processes)

Validated

Not Validated

Validation in Progress

Attach Cleaning Logs for Recent Cleaning Cycle

Signature of Person Performing Cleaning Verification

Maintenance & Calibration

8 of 10

Addresses the maintenance and calibration of equipment and instruments.

Last Calibration Date - Equipment X

Calibration Result - Equipment X

Tolerance Limit - Equipment X

Calibration Standard Used

NIST traceable

In-house Standard

Other (specify in LONG_TEXT)

Details of Calibration (if applicable)

Calibration Status

In Tolerance

Out of Tolerance

Requires Adjustment

Calibration Certificate

Next Calibration Due Date - Equipment X

Deviations & Corrective Actions

9 of 10

Covers the process for identifying, documenting, and resolving deviations from established procedures.

Detailed Description of Deviation

Date of Deviation Occurrence

Time of Deviation Occurrence

Quantity/Volume Affected (if applicable)

Severity Level (e.g., Minor, Major, Critical)

Minor

Major

Critical

Root Cause Analysis - Detailed Explanation

Corrective Action Plan - Steps to be taken

Planned Completion Date of Corrective Action

Verification Method (How was effectiveness confirmed?)

Review of Records

Re-testing

Inspection

Other

Signature of Person Implementing Corrective Action

Change Control

10 of 10

Addresses procedures for managing and documenting changes to manufacturing processes, equipment, or materials.

Description of Proposed Change

Rationale for Change (Justification)

Type of Change

Minor

Major

Technical

Personnel

Equipment

Estimated Impact on Production (e.g., %)

Proposed Implementation Date

Supporting Documentation (e.g., Drawings, SOP revisions)

Affected Areas/Departments

Manufacturing

Quality Control

Engineering

Maintenance

Risk Assessment Summary

Change Control Status

Proposed

Under Review

Approved

Rejected

Implemented