SOPs

SOP For Line Clearance

Objective:   To lay down the procedure for the line clearance of the area / equipment. 2. Scope: This SOP isĀ applicableĀ to all stages of manufacturing operations carried out before the start of operation/stage during the manufacturing/packing to avoid any...

SOP for Sampling

1.Objective :    To lay down the procedure for sampling of intermediates, drug substances, drug products. 2. Scope :     This procedure is applicable for Pharmaceutical Industry of API as well as formulations. 3. Definition : Sample: Sample is a portion of...

SOP- Responsibility of Production Dept.

1.Objective :  To define the responsibilities of  Production Department. 2. Scope: This procedure is applicable to all personnel working in Production Department. 3. Responsibilities : Microbiology Person / Designee, Microbiology Head 4. Procedure : Strict adherence to approved procedures.To ensure Good Manufacturing Practices.To follow...

SOP- Responsibility of Microbiology Dept.

1.Objective :  To define the responsibilities of Microbiology Department. 2. Scope: This procedure is applicable to all personnel working in Microbiology Department. 3. Responsibilities : Microbiology Person / Designee, Microbiology Head 4. Procedure : Strict adherence to approved procedures.To ensure Good Laboratory Practices.To follow good documentation...

SOP – Planned Modification

1.Objective: To lay down the procedure for handling of Planned Modification System. 2. Scope : This SOP is applicable to addition, deletion &/or modification of area, equipments, utility, system, machines. 3. Responsibilities : User Department, QA, Engineering 4. Definitions: Planned Modification: A modification which is planned for...

Engineering SOP -FAT : Factory Acceptance Test & SAT : Site Acceptance Test

Factory Acceptance Test (FAT) Inspection and static &/or dynamic testing of system or major system component to support the qualification of an equipment/system conducted & documented at a supplier siteEstablishing documented evidence that the vendor fabrication process or material...

SOP: Handling of Returned Goods

1.Objective : To lay down the procedure for handling of returned goods from distributor / customer end. 2. Scope: This procedure is applicable for identifying, holding and/or disposition of Drugs Product & Drug Substances returned from...

SOP : Responsibilities of Quality Control Dept.

1.Objective : To define the responsibilities of Quality Control Department. 2. Scope : This procedure is applicable to all the personnel working in Quality Control Dept. 3. Responsibilities : QC Analyst, QC in Charge, Lab Technicians, QC Reviewer, QC Section Head,...

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