1.0 PURPOSE
To lay down the procedure for cleaning of equipment.
2.0 SCOPE
2.1 This procedure is applicable in Production.
3.0 RESPONSIBILITY
3.1 Personnel - Production
3.2 Manager -Production
4.0 ACCOUNTABILITY
4.1 Manager – Quality Assurance
5.0 PROCEDURE
5.1 All the equipment associated with the processing of a batch shall be cleaned before use.
5.2 There shall be an SOP for cleaning of each equipment. The procedure shall include, but are not limited to the following.
5.2.1 Responsible person for carrying out the cleaning.
5.2.2 Frequency of cleaning.
5.2.3 Methods of dismantling and cleaning of the equipment.
5.2.4 Update the equipment status label.
5.2.5 Protection of clean equipment from contamination prior to use.
5.2.6 Inspection of equipment for cleanliness immediately before use.
5.3 Cleaning operation shall be performed as per the respective equipment cleaning SOP.
5.4 Any one of the cleaning process shall be followed based on the manufacturing situation(s).
5.4.1 Batch to batch cleaning
5.4.2 Periodical cleaning
5.4.3 Product change over cleaning
Note: Evaluation of cleanliness described in this SOP is general. This will be changed to meet the product specific requirements.
5.5 Enter batch to batch cleaning details in the respective Batch Production and Control Record. Enter periodic and product change over cleaning in respective batch cleaning record.
5.6 The cleaning procedures shall be established for all manufacturing equipments. These procedures shall be identified in the Batch Production and Control Record and Batch Cleaning Records.
5.7 The following types of cleaning processes shall be performed and evaluated based on the manufacturing situation(s) described
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Type of cleaning |
Frequency |
Evaluation and Acceptance criteria |
Batch to batch cleaning |
In between two batches of same product. |
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Periodical Cleaning |
Within 30 days in continuous manufacturing of a product. The periodicity can be changed based on the product requirement. |
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|
Product change over cleaning |
Intermediate to intermediate of same product Ex.: Stage III of Product A to Stage IV of product A |
|
|
Intermediate to intermediate of same product Ex.: Stage IV of Product A to Stage III of product A |
|
|
|
Intermediate to intermediate of different product Ex.: Stage V of Product A to Stage VI of Product B |
|
|
|
Intermediate to Active Pharmaceutical Ingredient of same product |
|
|
|
Intermediate to Active Pharmaceutical Ingredient of different product |
(Less than 10 ppm of previous product) |
|
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Final stage of Active Pharmaceutical Ingredient to Final stage of different Active Pharmaceutical Ingredient |
|
* Chemical testing- Evaluation of cleanliness on the basis of analysis of cleaning agent.
5.8 During cleaning validation identified parameter are subjected for testing .
5.9 For intermediate to intermediate of same product or different product or vice versa, only visual observation will be carried out after the cleaning validation.
And verification of cleaning validation process will be carried out once in six
months for all the parameter considered for validation.
5.10 Batch Cleaning Records shall be prepared for Periodic cleaning and Product change over cleaning as per Annexure-I and Annexure-II respectively.
5.11 Production department shall request the batch cleaning record to QA through Batch Cleaning Record issue request, Annexure - V
5.12 Batch cleaning records shall be issued by QA and the same shall be entered in “Batch cleaning record issue and receipt record”, Annexure – VI.
5.13 Raw material request for total chain of equipment shall be sent to warehouse from production department through Raw material Issuance Record, Annexure – III.
5.14 The break up details of raw materials with respect to equipment shall be entered in raw material requirement list, Annexure – IV. This list shall be attached with corresponding raw material issuance record.
5.15 In case if the cleaned equipment is not used for a period of over 7 days, Batch to Batch Cleaning shall be performed before using the equipment.
5.16 In case of preventive maintenance in side the equipment, Batch to Batch Cleaning shall be performed before using the equipment.
5.17 After the completion of batch operation tick mark (?) “ TO BE CLEANED ” on the status label of equipment.
5.17.1 Equipments like Blender, Sifter and Multimill shall be covered with the Polythene cover when not in use
5.17.2 Any equipment labeled “TO BE CLEANED “ shall not be used.
5.17.3 While the cleaning is Under Progress the status shall be tick marked (?) as “ UNDER CLEANING “.
5.18 Equipment shall be tick marked (?) “ CLEANED ” after the completion of the cleaning operation.
5.19 Equipment like Reactor, Centrifuge and Dryer shall be properly closed when not in use.
5.20 The cleaning time shall be entered in the equipment Usage log as per QA053 Annexure-I.
5.21 Before using the equipment, the cleanliness shall be physically checked and verified.
5.22 After product change over cleaning, swab and or rinse sampling shall be carried out and analyzed for residual content.
5.23 The acceptance limits for the residual content shall be identified in the individual cleaning validation protocol.
5.24 The batch cleaning record numbering system is as follows
5.22.1 Batch Cleaning Record Numbering System
END OF DOCUMENT
Cleaning of equipment, production
