SAFFRON PHARMACEUTICALS (PVT.) LTD.

PRODUCTION DEPARTMENT Title: Standard Procedure Maintenance of Equipments for Preventive Document#:PR/GN/SP/02
1 Issue date: 08-06-2011 Revision date/#:07-062013/00 Page #: 1/2

Prepared By/on: In-charge Pharmacist

Checked By/on: Production Manager

Approved By/on: Quality Assurance Manager

Authorized By/on: Deputy Plant Manager

1. Objective: The objectives of preventive maintenance include the following: i. To avoid, as far as possible, failure or breakdown of equipment during normal operation. ii. To maximize the operating efficiency of the equipment. iii. To ensure safety in operation. iv. To minimize the cost of production by maximizing the availability of equipment for production. v. To improve the product quality by maintaining the operating parameters of equipment within control limits. 2. Scope: It is applicable to all the equipments used in production area. 3. Responsibilities: i. Production Supervisor ii. Operator iii. Maintenance Department Personnel 4. Procedure: i. Preventive Maintenance (PM): The care and servicing by personnel for the purpose of maintaining equipment and facilities in satisfactory operating condition by providing for systematic inspection, detection, and correction of incipient failures either before they occur or before they develop into major defects. ii. Preventive maintenance is conducted according to the schedule given in the start of the year. iii. Before starting PM of equipment, the person from maintenance department will ask about the availability of that equipment from

production pharmacist or production supervisor whether the equipment is being used in any process or not. iv. After confirming the availability of that equipment, PM will be started. v. Status on the door of that room will be mentioned as UNDER PREVENTIVE MAINTENANCE. vi. A tag of UNDER PREVENTIVE MAINTENANCE will also be pasted on that equipment. vii. On starting the PM, equipment will be checked for all the check points e.g. gear, cam, belt, bearings, shaft, chain, oil, spring, motor etc given in the Preventive Maintenance Card.

SAFFRON PHARMACEUTICALS (PVT.) LTD.

PRODUCTION DEPARTMENT Title: Standard Procedure Maintenance of Equipments for Preventive Document#:PR/GN/SP/02
1 Issue date: 08-06-2011 Revision date/#:07-062013/00 Page #: 2/2

Prepared By/on: In-charge Pharmacist

Checked By/on: Production Manager

Approved By/on: Quality Assurance Manager

Authorized By/on: Deputy Plant Manager

viii. If replacement is done of any part of equipment, its record will be maintained on Preventive Maintenance Card and also on log book of that equipment. ix. If the part to be replaced is need to be taken out of factory, a gate pass of that part will be made and its record will be kept in the file of Outward Gate Pass. x. After completion of PM, production supervisor will verify it and its entry will be made on Preventive Maintenance Card. 5. Related Documents: Preventive maintenance card as per DOC# EM/FM/MN/001 6. Distribution list: Production manager, all section in-charges, controlled copy to Q.A. 7. Revision history: Being issued first time