- SOP on Precautions during on line maintenance of machine and re-start operation.
- Objective:To lay down a procedure for precautions during on line maintenance of machine and checks to start its operation.
- Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company.
- Production Supervisor / Officer / Executive shall be responsible for implementation of this procedure.
- Head-Production / designee shall be responsible for compliance of the procedure as per this SOP.
- Head-Production and head QA shall be accountable for compliance of the procedure as per this SOP.
- Abbreviations and Definitions:
- Type-A -Product to Product cleaning procedure
- Type-B – Batch to Batch cleaning procedure
- Switch ‘OFF’ the machine when online maintenance shall be required.
- Prepare the maintenance memo with detailed nature of breakdown and forward it to the engineering department.
- Cover the online product or material collecting containers with the lid and keep them aside on a pallet.
- Allow the engineering person to perform the maintenance work. After the completion of the maintenance work ensure that the maintenance is done properly.
- Clean the machine with cleaning procedure Type-A if contact parts included in the maintenance or otherwise clean the machine with cleaning procedure Type-B.
- If the maintenance work of machine / equipment continues for more than 24 hours remove the material / product from respective machine and transfer the material in containers duly labeled as per current version of SOP. to the quarantine.
- Clean the whole machine / equipment with cleaning procedure Type-A.
- After completion of cleaning switch ‘ON’ the machine.
- Run the machine in empty condition to check for the satisfactory maintenance work.
- In case of time specified for manufacturing / packing operation, after the maintenance work of the relevant equipment gets completed, carry out the manufacturing operation for remaining period of time left out for completion of operation.
- Record the details of machine / equipment breakdown in relevant machine logbook..
- If printers attached to the PLC based equipment or weighing balance are under maintenance then record the data of the process manually in the space provided in respective BMR.
- In case of compression / filling operation, collect the tablets of first 2 to 3 rotations as rejected residues with proper label on their polybags.
- In case of compression / filling operation, take the new sample after the machine trial and again check the in process parameters of tablets / capsules and record in the BMR of respective product.
- Forms and Records:
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production, Quality Assurance
|Reason for revision|
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube