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
SOP FOR ACCIDENT /INCIDENT REPORTING PURPOSE : Any Accident / Incident is a symptom, of some thing wrong in the system. Detailed investigation helps in uncovering the deficiencies in the system and find out the root cause which should be eliminated to prevent reoccurrence of such accidents / incidents. Hence, all accidents / incidents resulting in … Read more
SOP FOR EQUIPMENT TAGGING SYSTEM PURPOSE : Accidents are often caused due to operation of some equipment at the time when people are attending / working on it due to improper communication about the equipment being given or taken for maintenance. Tags tied on the operating devices of equipments states about the status of the … Read more
SOP FOR MAINTENANCE WORK PERMIT PURPOSE : The purpose of this procedure is to establish proper and adequate communication between department originating a request for some maintenance / civil jobs and personnel actually performing these jobs. SCOPE : For all jobs to be carried out in the plant premises where there is an interaction of … Read more