- Objective:To lay down a procedure for the control of change parts.
- Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company for controlling the various change parts of the machines/equipments.
- Trained Worker / Operator shall be responsible for control of change parts.
- Production Supervisor / Officer shall be responsible for implementation of this SOP.
- Head-Production / designee shall be responsible for compliance of this SOP.
- Accountable:Head-Production and Head QA shall be accountable for compliance of this SOP
- Abbreviations and Definitions:
- Change part – Component of the equipment which is required to be fitted on the machine for a product.
- The drawing /layout of change parts shall be provided and approved by concerned scientist from R&D, before Initation for procurement of any change parts.
- After receiving the approved layout or drawing shall be approved by production and than by QA.
- The master copy of approved drawing/ layout shall be kept by QA and control copy of same shall be kept with Production.
- A control copy of approved drawing shall be given to Material Management department for procurement purpose.
- After receiving new change part set, entry shall be made in ‘Change Parts Register’ (Annexure-1).
- Production Supervisor / Officer shall be inspect every change part for their specifications, dimensional checks, gasket-tubing etc. as per the purchase order.
- Trial of the change part on the machine shall be taken.
- The receiving of change parts and acceptance / rejection activities shall be done in coordination with material management.
- Fluid Bed Drier / Processor bags: Product dedicated FBD bags shall be numbered with the equipment identification number and product name.
- Dies and Punches shall be controlled through respective SOP and Sieves and Screens shall be controlled through respective SOP.
- Replace the change parts of machine in case of product changeover as per pack style.
- After the packing of product is completed, dismantle the change parts.
- Place them on a polythene bag spreaded on the trolley.
- Clean all the non contact change parts by means of vacuum and dry non-shredding cloth.
- Clean all product contact change parts with sufficient quantity of sufficient potable water and rinse with purified water. Apply compressed air and dry with dry non-shredding cloth.
- In case of products containing greasy products like Soft Gel, Ointment clean with 0.5 % w/w sol. of Sodium lauryl sulfate as cleaning agent. Wash with sufficient quantity of potable water till removal of cleaning agent and rinse with purified water. Dry with compressed air and clean lint free cloth.
- Trained worker / Operator shall be check visually that all the change parts are clean.
- Wrap the cleaned change parts with clean stretch wrap and transfer to their designated place.
- Check all the cleaned change parts for any damage and note the same in product change
parts register as per respective record.
- During the replacement of change parts of previous product, check for the availability of the change parts for the next product to be taken for packing.
- Make an entry of machine change parts which are required for the next product setting in ‘Product Change Parts Register’ as per their respective records.
- Bring the required change parts to the respective machine for machine setting.
- Disposal of damaged change parts shall be done as per respective SOP.
- Forms and Records
- New Change Parts Register – Annexure-1
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production, Material Management Department and Quality Assurance
|Date||Revision Number||Reason for revision|
New Change Parts Register
|Date||Supplier Name||Item description||Quantity||Mother Equipment Name & ID Number||Layout No.||Indented use of product Name||Remarks OK/ Not OK||Signature & Date|
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