Objective of this report is to check and provide documented evidence of its performance as per the predetermined acceptance criteria.
Refer working and principle of RMG https://pharmaceuticalupdates.com/2020/04/27/working-and-principle-of-rapid-mixer-granulator-rmg/
The scope of this report is limited to equipment ID No. XYZ.
3. QUALIFICATION TEAM AND RESPONSIBILITIES:
|DEPARTMENT||NAME AND SIGNATURE||RESPONSIBILITY|
|Quality Assurance||To prepare performance qualification protocol and report. To co-ordinate the entire qualification activity.|
|Production||To execute qualification study in co-ordination with other departments.|
|Quality Assurance||To execute qualification study in co-ordination with other departments.|
|Maintenance||To review the qualification documents.|
|Head – Quality Assurance||To approve qualification protocol & report.|
4. EQUIPMENT DESCRIPTION:
Equipment description shall be match as per design qualification protocol.
5. ACCEPTANCE CRITERIA:
Performance Qualification of the equipment shall be in accordance with the parameters given in FORM – A of this report.
Perform the qualification as per following form,
Performance of Equipment
PERFORMANCE OF EQUIPMENT
Performance of the equipment is verified by simulating the normal operation for dry mixing, granulation and milling of the ingredients. While doing the exercise consideration is given to the operational range of the equipment that is at minimum level (20% of capacity), optimum level (50% of the capacity) and maximum level (80% of the capacity). At the end of the granulation process wet mass is checked for its physical appearance.
1.0 Minimum Level: (20 % of capacity)
Product Name :
Batch No. :
Theoretical Batch Size :
Practical Batch Size :
1.1 Dry Mixing:
Uniform mixing of raw materials i.e. active and inactive materials is checked by collecting samples from 10 different locations for blend uniformity test. The result of blend uniformity test, process parameters of equipment i.e. mixer speed, chopper speed and end point ampere reading are recorded in following tables.
1.1.1 Acceptance Criteria:
Mixing of active material shall be uniform.
Blend Uniformity: 90.0 % to 110.0 %
% RSD: NMT 6.0 %
1.1.2 Process Parameters Data:
|sr no.||Step||Mixer Slow||Mixer Fast||Chopper Slow||Chopper Fast||End Point Ampere||Observation entered by/date|
|1||Dry mixing cycle|
1.1.3 Blend Uniformity Test Result:
|Sr. No.||Locations||Assay in %||Result entered by/date|
|1||Left – Top|
|2||Left – Bottom|
|3||Right – Top|
|4||Right – Bottom|
|5||Middle – Top|
|6||Middle – Bottom|
|7||Front – Top|
|8||Front – Bottom|
|9||Back – Top|
|10||Back – Bottom|
1.2 Wet Mixing (Binder Addition):
After addition of binder solution, checked the wet mass, process parameters of equipment i.e. binder solution temperature, mixer speed, chopper speed and end point ampere reading. The observations are recorded in following tables.
1.2.1 Acceptance Criteria: Wet mass shall be coherent.
1.2.2 Process Parameters Data:
Binder solution temperature:
|Sr No.||Steps||Mixer Slow||Mixer Fast||Chopper Slow||Chopper Fast||End Point Ampere||Observation entered by/date|
|1||During binder solution addition.|
|2||After completion of binder solution addition.|
|3||Additional purified water, if added. Quantity :|
1.2.3 Physical Appearance of Wet Mass:
1.3 Wet Mass Milling:
The wet mass after granulation is passed though the cone mill and the same is checked visually for its size and uniformity.
1.3.1 Acceptance Criteria: Wet granules size shall be uniform.
1.3.2 Physical Appearance of Wet Mass:
|1||Visually check wet granules for its size.|
Repeat the above mentioned process for optimum level (50% of the capacity) and maximum level (80% of the capacity).
7. Deviation Report:
Any deviation reported during process with respect to acceptance criteria shall be justified and it’s it’s impact on equipment qualification shall be evaluated.
8. CHANGE CONTROL:
Change control number shall be mentioned.
9. List of Annexures:
Annexures shall be attached to the PQ Report.
10. Summary and Conclusion of Performance Qualification:
The results and final conclusion shall be mentioned that the equipment performance is found satisfactory at load condition and analytical and physical parameters performed at different capacities are found satisfactory.
11. Certification of Performance Qualification:
Performance Qualification is satisfactory Yes/No
Hence equipment can be used for routine use Yes/No.
Certification shall be taken from Quality Assurance before use.