Follow
1.0 OBJECTIVE
To provide a procedure for fulfillment of production plan and meeting delivery schedule of Infusions, ION, Vision, PFS and LYO Units.
2.0 SCOPE
This SOP shall be applicable for Production and P & IC Departments.
3.0 ASSOCIATED DOCUMENTS
Not applicable.
4.0 RESPONSIBILITY/ACCOUNTABILITY
4.1 Employees of Production and P & IC Departments shall be responsible for implementing the procedure.
4.2 Head of P & IC and Manager, Production shall be accountable for ensuring implementation of the procedure.
5.0 ABBREVIATIONS AND DEFINITIONS
5.1 P& IC – Planning and Inventory Control
5.2 ION – Injectable, Ophthalmic & Nebulizer
5.3 PFS – Pre-filled Syringe
5.4 LYO – Lyophillized & Liquid Vial
6.0 PRECAUTIONS /SPECIAL INSTRUCTIONS
Not applicable.
7.0 PROCEDURE
7.1 P&IC Department shall prepare a monthly production order (Form No. GE014-01) by evaluating the sale, opening stock, approved and intermediate finished stock and material availability. This monthly production order shall be sent within the first week of the concerned month to the Head of Production.
7.2 Manager, Production shall review the plan (Form No. GE014-01). Officer/Sr. Officer shall prepare a plan analysis (Form No. GE014-02) which is checked by Sr. Officer/Asst. Manager. If the plan is within the production capacity, Production Manager shall analyze & approve the plan analysis and submit it to Executive Director, Production. Manager, Production shall then approve a weekly production program (Form No. GE014-03) prepared by Sr. Officer/Asst. Manager for Infusions Unit and a monthly production program (Form No. GE014-04) for ION, Vision, PFS and LYO Units and distribute to Production Department for execution and other concerned Departments for information.
7.3 If there is any discrepancy between the plan and capacity, Manager, Production shall inform Executive Director, Production and P & IC Department. Together a necessary actions shall be decided, i.e. revision of plan or product mix, or requirement of additional working hours or changing the production schedule.
7.4 The plan shall also be reviewed by P & IC Department in case of material shortage, institutional order or production interruption.
7.5 The Production personnel shall prepare daily production status for Infusions Unit (Form No. GE014-05) and (Form No. GE014-06) for other Units. Also a daily packaging status (Form No. GE014-07) shall be prepared & send to Manager, Production in the following day.
7.6 A Batch wise Production Report (Form No. GE014-08) shall be sent to the Accounts Department, P & IC Department and Executive Director, Production after completion of the month to get the status of the whole month.
7.7 A batch wise Monthly Summary Production Report (Form No. GE014-09) shall be prepared by Officer/Sr. Officer, checked by Sr. Officer/ Asst. Manager and approved by Manager, Production within the first week of the following month and shall be submitted to Executive Director, Production.
