- Objective:To lay down a procedure for Movement of Man and Materials in Production area.
- Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical Company name with location.
- Trained worker / Operator shall be responsible for Movement of material in Production Area as per this SOP.
- Production Supervisor / Officer, Store Supervisor / Officer shall be responsible for implementation of this SOP.
- Housekeeping / supervisor shall be responsible for movement of scrap / waste material and transfer to scrap yard.
- Head Admin shall be responsible for proper movement of scrap.
- Head-Production / Head-Store / designee shall be responsible for compliance of this SOP.
- Abbreviations and Definitions
S.S.- Stainless Steel
SOP – Standard Operating Procedure
QA – Quality Assurance
IPC – In process containers
FG – Finished Goods
- Raw Material Movement in Production Area
- Transfer the issued Raw material in clean S.S. cage / S.S.pellete from store to batch staging area.
- After taking the line clearance of respective areas and equipments, verify the weight of the raw material in batch staging area on precalibrated weighing balances. Then transfer the required raw material lot wise to respective fabrication material air lock/ material air lock for core corridor (for coating material) in IPC bins / pallets.
- Persons shall clean the outer part of IPC bins / pellet and hands aseptically by the disinfectant with cleaned cloth.
- Keep the IPC bins / pellets inside the yellow line in the material air locks.
- The person keeping the material shall not cross the yellow line.
- Packing Material Movement in production area
- Transfer the issued primary packing material with help of SS trolley / cage from the store to the primary packaging area and secondary packing material to secondary packaging area.
- After taking the line clearance of respective machine and area, the machine operator shall transfer the material to respective area / material air lock under the supervision of production supervisor / officer.
- Movement of bulk granules in production area
- After blending and sampling of material, the materials shall be stored in granules storage area.
- After getting approval from QC for compliance of results and taking the line clearance of respective compression machine and area, required bins is transfer through the lift into bin feed area (in case of tablet block).
- Movement of bulk tablet / capsule
- After the compression of tablets/coating of the tablets, the tablets shall be stored in HDPE container and transfer to bulk storage area of the respective block, the same shall be entered in the inward / outward register.
- In case of Capsules: After the filling of capsules, the capsule shall be stored in HDPE container and transfer to bulk storage area of the respective block, the same shall be entered in the inward / outward register.
- Movement of bulk Soft Gelatin Capsule in Softgel block
- Movement of bulk of soft gelatin capsules are as under:
- Raw Material Movement in Production Area
1. Encapsulation 2. Pre drying 3.Drying 4. Visual Inspection 5.printing 6.Visual Inspection 7. Bulk storage area 8. Blister Machines 9.material air lock
- Movement of FG for Tablet /Liquid/Softgel block to FG store
- After packing, the finished products shall be transferred from packing area to finished goods store as per SOP Transfer of Finished products from production to Finished Goods Store.
- Movement of Scrap
- Defoiled strips along with empty strips, Blister Machine scrap shall be labeled by production supervisor / officer and countersigned by IPQA person and shall be transferred through material air lock.
- Rejected Bottles/ROPP caps shall be deformed in filling area and labeled as scrap by production supervisor / officer and countersigned by IPQA person and shall be transferred to scrap area.
- Trained worker from scrap room shall transfer the checked and labeled poly bags from material air lock to scrap room and shall shred these materials with the help of shredding machine.
- The shredded material again shall be kept in a poly bag and tightened with a cable tie after checking from production supervisor / officer and IPQA person.
- The shredded material shall be handed over to Admin person through other door of the scrap room.
- Empty drums and rejected bottles, Gelatin Ribbon, waste gelatin mass and other non recoverable rejection shall be sent for incineration through scrap room labeled by production supervisor / officer and countersigned by IPQA person.
- The scrap collected in waste bins of production area shall also move out through the scrap room under the supervision of Admin and Housekeeping supervisor.
- Only authorized persons are permitted to enter in Production Area. The persons deployed for a particular section shall move to that section only.
- The areas for storage of materials shall be under lock and key. Any work in these areas shall be allowed only after permission of respective area in charge.
- The bulk storage area and exhibit batches storage area entry / exit shall be recorded in log sheet, only after permission of respective area in charge.
- Designated areas for change parts, dies and punches, sieves shall be controlled through` respective log sheets/log books.
- Manpower Movement from primary change room to core area and exit.
- in case of tablet manufacturing, the manpower shall move from primary change room then outer corridor to secondary change room of respective fabrication area.
- In case of compression, coating and blister packing machine the manpower shall move from primary change room then outer corridor through the secondary change room of core to the respective area.
- In case of packing hall the manpower shall move from primary change room and outer corridor to the packaging hall directly.
Note: Worker and Supervisor going to batch staging area for verification of issued raw
material shall open the booty and secondary gown in secondary change room of fabrication.
- Forms and Records
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production and Quality Assurance.
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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