Autocoater Performance Qualification verifies that the autocoater consistently produces coated tablets meeting predefined critical process parameters quality attributes under routine operating conditions. All outlines the GMP-compliant PQ procedure, acceptance criteria, pre-requisite, and best practices for pharmaceutical manufacturing.
Read Article => Quality Control Lab Installation Qualification – complete facility installation
Table of Contents
| Title | Page No. |
| Protocol Pre-Approval | |
| Qualification Team and Responsibilities | |
| Objective | |
| Scope | |
| Process Description | |
| Re-Qualification Criteria | |
| Pre-Requisites | |
| Calibration Status of Test Instruments | |
| Batch Information Test Product | |
| Performance Qualification Evaluation | |
| Performance Evaluation Using Placebo | |
| Performance Evaluation Using Batch | |
| Deviation, Change Control and Corrective Action | |
| Summary, Conclusion and Recommendation | |
| References | |
| Abbreviation | |
| Protocol Post Approval |
Protocol Pre approval for Autocoater Performance Qualification:
Prepared by:
| Department | Name | Signature | Date |
| Quality Assurance (Officer/ Executive) |
Reviewed by:
| Department | Name | Signature | Date |
| Quality Assurance (Executive/ Manager) | |||
| Production (Executive/ Manager) | |||
| Engineering (Executive/ Manager) | |||
| Quality Control (Executive/ Manager) |
Approved by:
| Department | Name | Signature | Date |
| Quality Assurance (Head QA) |
Qualification team and responsibilities for Autocoater Performance Qualification:
Qualification team shall be complied of personnel from following department:
| Department | Responsibilities |
| Quality Assurance | Quality Assurance Department shall be responsible for: Initiation, Review, Approval and Compilation of the Performance Qualification Protocol cum Report.Review of Performance Qualification Protocol cum Report after Execution.Coordination with Production and Engineering to carryout Performance Qualification and Monitoring of Performance Qualification Activity.Post approval of Performance Qualification Protocol cum Report after Execution.Approve any change control generated during the Performance Qualification Study. |
| Production | Production Department shall be responsible for: Review & Pre Approval of Performance Qualification Protocol cum Report.To coordinate & support for execution of Qualification Study as per Protocol.Post approval of Performance Qualification Protocol cum Report after Execution. |
| Quality Control | Quality Control Department shall be responsible for: Review & Pre Approval of Performance Qualification Protocol cum Report.Analytical Support (Microbiological Testing/ Analysis).Post approval of Performance Qualification Protocol cum Report after Execution. |
| Engineering | Engineering Department shall be responsible for: Review & Pre Approval of Performance Qualification Protocol cum Report.Coordination, execution and technical support in Smart Coater Performance Qualification Activity.Responsible for Trouble shooting (if occurs during execution).Review of Performance Qualification Protocol cum Report after Execution. |
Objective of Autocoater Performance Qualification:
Describing the procedure for qualification of the Auto Coater and its ancillary system as intended throughout the anticipated operating range to meet the criteria of the equipment and ancillary system for qualification.
- Demonstrate that the procedure for performance test and operating range of the Auto Coater is competent for reproducibility and consistently within its full dynamic range of operation according to specifications and as per cGMP guidelines.
- Document the Performance of operational ranges of the Smart Coater.
- To provide the detailed report of the test to be carried out for performance of Smart Coater assures that the operating range of the Smart Coater performance is adequate to support the process for which the system is.
Scope including Autocoater Performance Qualification:
- The Scope of this Qualification Document is limited to the Performance Qualification for Auto Coater with cGMP Model procures from ACG Pharma Technologies Pvt. Ltd.installed in the Coating Section, Production area at XYZ company.
- This Protocol cum Report defines the responsibilities, procedures, documentation, references, acceptance criteria, change control and qualification criteria to be used during Performance Qualification of the Smart Coater.
- This Protocol cum Report provides all the relevant information of performance qualification activity for Smart Coater and all the observations of In-Process checks and analytical results of analyzed samples.
Process Description:
- Auto Coater utilize the principle of spraying of solution with optimum atomization with maximum even distribution of coating solution on the tablet surfaces with properly heated clean process air through the bed to provide rapid drying and control of dust and coating liquid. Thus, the efficient and uniform coating and drying takes place between coats.
- In Auto Coater, high volume of air moves through the tablet bed, this is achieved by perforation on the cylindrically portion of the pan. An exhaust plenum is positioned on the outside of the pan at the point where the tablet bed is tumbling during coating. The coating pan is totally enclosed thus allowing supply of hot / temperature controlled / high volume of air to be introduced. This results in a consistent air flow pattern, greater drying capacity, a fast coating rate and efficient dust & solvent control.
Re-Qualification Criteria:
Qualification of the Smart Coater is applicable when:
- Modification or any spare parts of Smart Coater are replaced that have a direct impact on the performance of the equipment.
- Smart Coater is sent for major repairing or modification.
- Smart Coater is transferred from one location to another within the same premises.
- If the trend data of a particular product shows variation in the validated process then the parameters attributed to the smooth operation of Smart Coater to qualified and evaluated.
- Periodic Qualification.
Pre-requisites for PQ:
Verification of Documents:
Ensure that, below listed documents are available before the Performance Qualification activities
are carried out to check the performance.
| Name of Document | Document No./ SOP No. | Availability Status (YES/NO) | Checked by Engineering (Sign/Date) | Verified by Quality Assurance (Sign/Date) |
| DQ Protocol cum Report | ||||
| IQ Protocol cum Report | ||||
| OQ Protocol cum Report | ||||
| SOP for Operation and Cleaning of Auto Coater. | ||||
| SOP for Preventive Maintenance of Auto Coater. |
Inference:
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Calibration Status of Test Instruments used for Autocoater Performance Qualification
| Name of Instrument | Purpose of Instrument | Instrument ID. No. | Calibration Done On | Calibration Due On | Checked by Engineering (Sign/Date) | Verified by Quality Assurance (Sign/Date) |
Inference:
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Test Product Batch Information:
Ensure that, below listed, required product is available before the qualification activities are carried out:
| S. No. | Product Name | Batch No. | Batch Size | Mfg. Date | Exp. Date |
| Placebo | |||||
| Batch | |||||
Inference:
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Performance evaluation using placebo:
- To verify the performance of equipment in the range of operational parameters establish in the operational qualification activity.
- To establish the performance based range of operating parameters for performance qualification activity using placebo formulation.
Procedure:
- Load the Placebo Formulation in the range of 80% of capacity to the coating pan of Auto Coater.
- Perform the coating at optimum coating parameters.
- Collect the samples of coated products from 3 different locations after completion of coating process.
- Analyze collected samples for description, dimension, average weight, uniformity of weight and % of weight gain.
Report of Performance Evaluation using Placebo:
Coating Parameters:
| Coating Parameters | Set Values | Observed Values |
| Product Load (Kg) | ||
| Pan RPM | ||
| Tablet Bed Temperature | ||
| Atomizing Air Pressure | ||
| Distance of Tablet Bed to Gun | ||
| Spray Rate | ||
| Inlet Air Temperature | ||
| Outlet Air Temperature | ||
| Before Coating Drying Temperature | ||
| Before Coating Drying Time | ||
| After Coating Drying Temperature | ||
| After Coating Drying Time |
Inprocess for various sampling location
| Test Parameters | Results | |||||||||
| Description | ||||||||||
| Weight of 20 Tablets | ||||||||||
| Average weight of 20 Tablets | ||||||||||
| % Weight Gain | ||||||||||
| Individual Weight Variations | ||||||||||
| % Variation | (+) (-) | |||||||||
| Length/ Diameter (mm) | ||||||||||
| Minimum: Maximum: | ||||||||||
| Width (mm) | ||||||||||
| Minimum: Maximum: | ||||||||||
| Thickness (mm) | ||||||||||
| Minimum: Maximum: | ||||||||||
Inference:
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Performance Evaluation Using Batch:
- To verify the performance of Smart Coater in the established operating range.
- To establish documented evidence that the Smart Coater is performing consistently and the results of all test parameters meet the pre-defined acceptance criteria of coated products.
Procedure:
- Coating shall be performed on 3 different lots of same product or 3 different batches of same or different products.
- Load the product to the pan of Auto Coater.
- Perform coating at coating parameters as specified in the BMR of product.
- Collect the samples from different locations after completion of coating process.
- Check the In Process Parameters of Coated tablets.
Observation For Evaluation Of Performance Using Batch
Coating Parameters:
| Drying Parameters | 1st Batch | 2nd Batch | 3rd Batch | |||
| Standard | Observed Values | Standard | Observed Values | Standard | Observed Values | |
| Product Load (Kg) | ||||||
| Pan RPM | ||||||
| Tablet Bed Temperature | ||||||
| Atomizing Air Pressure | ||||||
| Distance of Tablet Bed to Gun | ||||||
| Spray Rate | ||||||
| Inlet Air Temperature | ||||||
| Outlet Air Temperature | ||||||
| Before Coating Drying Temperature | ||||||
| Before Coating Drying Time | ||||||
| After Coating Drying Temperature | ||||||
| After Coating Drying Time | ||||||
In Process Observation: 1st Batch:
| Test Parameters | Results | ||
| Sampling Location-I | Sampling Location-II | Sampling Location-III | |
| Description | |||
| Weight of 20 Tablets | |||
| Average weight of 20 Tablets | |||
| % Weight Gain | |||
| Length/ Diameter (mm) | Min: Max: Avg: | ||
| Width (mm) | Min: Max: Avg: | ||
| Thickness (mm) | Min: Max: Avg: | ||
| Disintegration Time (Minutes) | |||
In Process Observation: 2nd Batch:
| Test Parameters | Results | ||
| Sampling Location-I | Sampling Location-II | Sampling Location-III | |
| Description | |||
| Weight of 20 Tablets | |||
| Average weight of 20 Tablets | |||
| % Weight Gain | |||
| Length/ Diameter (mm) | Min: Max: Avg: | ||
| Width (mm) | Min: Max: Avg: | ||
| Thickness (mm) | Min: Max: Avg: | ||
| Disintegration Time (Minutes) | |||
In Process Observation: 3rd Batch:
| Test Parameters | Results | ||
| Sampling Location-I | Sampling Location-II | Sampling Location-III | |
| Description | |||
| Weight of 20 Tablets | |||
| Average weight of 20 Tablets | |||
| % Weight Gain | |||
| Length/ Diameter (mm) | Min: Max: Avg: | ||
| Width (mm) | Min: Max: Avg: | ||
| Thickness (mm) | Min: Max: Avg: | ||
| Disintegration Time (Minutes) | |||
Inference:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Deviation/Change Control:
Any Deviation or modification to the Performance Qualification shall be recorded.
| Specification | Deviation/Change Control | Checked by | Verified by |
Corrective Action: Corrective Actions to be taken up as per approved Change Control and record the Corrective Action.
Summary, conclusion and recommendation:
After completion of Performance Qualification activity, record the summary and conclusion for further action.
References:
The Principle References are as following:
- WHO TRS 109 Annex. 3 Appendix 6
- EudraLex Volume 4 – EU Guidelines for GMP Annex 15: Qualification and Validation
Abbreviations:
| Abbreviation | Full form |
| DQ | Design Qualification |
| G.M. | General Manager |
| ID | Identification |
| IQ | Installation Qualification |
| Kg | Kilograms |
| Max. | Maximum |
| Min. | Minimum |
| MOC | Method of Construction |
| NMT | Not More Than |
| No. | Number |
| OQ | Operational Qualification |
| PQ | Performance Qualification |
| QA | Quality Assurance |
| SOP | Standard Operating Procedure |
| Sr. | Serial |
| w/w | Weight by Weight |
Protocol post approval:
Approved By:
| Department | Name | Signature | Date |
| Production (Head) | |||
| Engineering (Head) | |||
| Quality Control (Head) | |||
| Quality Assurance (Head) |