OP on Issue of additional Raw and Packaging materials Objective: To lay down a procedure for issuing additional raw and packing material to the Production Department. Scope: This SOP is applicable for issuing additional raw and packing material to the Production Department at the formulation plant. Responsibility: Officer or above of Warehouse shall be responsible for issuing additional … Read more
SOP on Receive of Material Returned from Production Objective: To lay down a procedure to receive the materials returned from production department. Scope: This SOP is applicable to all raw and packing materials returned from production department to Warehouse of the formulation plant .This condition may arise due to Change in the production plan. Cancellation of … Read more
SOP On Handling of Raw & Packaging Materials Under Re-Test Due Objective: To lay down a procedure for Handling of Raw & Packaging Materials under Re-Test due. Scope: This SOP is applicable to all raw & packaging materials under retest due in warehouse. Responsibility: Warehouse personnel shall be responsible for intimating Quality control about the retest due. … Read more
SOP on Entry and Exit into Dispensing Booth Area Objective: To lay down a procedure for entry, and Exit into Dispensing Area. Scope: This SOP is applicable for entry, and Exit into Dispensing Area warehouse Department to the formulation plant. Responsibility: All concerned people entering into Dispensing Area. Accountability: Warehouse Head shall be accountable for the compliance of the … Read more
SOP on Receipt & Issue of raw & packaging materials in the material Stock Card (Top & Bottom Card). Objective : To delineate the procedure for the receipt, storage and approval / rejection of Raw and Packaging Materials in the Material Stock Card. Scope : This SOP is applicable for raw and packaging material warehouse in formulation … Read more
SOP on intimating Q.C. for retesting of raw material Objective: To lay down a procedure for intimating to Q.C. regarding the retest of raw material. Scope: This SOP applicable to all the SOPs of formulation plant. Responsibilities: Officer & above of Warehouse– to check the retest date of all the raw materials and intimate the same to Quality … Read more
SOP on Operation & Cleaning of Lift in Warehouse Objective: To lay down a procedure of operation & cleaning of lift in warehouse. Scope: This procedure is applicable into warehouse. Responsibility: Warehouse supervisory staff shall be responsible for operation and cleaning of Lift. Accountability: Head Warehouse shall be accountable for implementation and compliance of this SOP. Procedure: Cleaning … Read more
Mapping of the Environmental Conditions (Temperature and Relative Humidity) Objective : The objective of this validation study is to provide a document evidence of Temperature and Relative Humidity distribution in Ware House area against predetermined acceptance criteria. Scope : The scope of this protocol shall be applicable at formulation Plant. The validation study of the Temperature … Read more
SOP for Preparation of Validation and Qualification Protocols Objective : To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may affect the quality … Read more
SOP FOR MAJOR ACCIDENT/INCIDENT REPORTING PURPOSE : An accident always results in diversion of resources from any normal business activity. In certain cases, publicity generated from an accident can result in a damaging effect on the image of the company. Thus it is imperative that top management is informed immediately about such accidents so that appropriate … Read more