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CEHT (Clean Equipment Hold Time Study)

Why is the CEHT important for the control of a cleaning process? Essentially the reason is that nothing stays clean forever. It should be realized that recontamination of the equipment may be an event-related...

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-Responsibility of Quality Unit

1.Objective :  To define the responsibilities of Quality Unit. 2. Scope: This procedure is applicable to all personnel working in Quality Unit. 3.Responsibilities : Quality Control, Quality Assurance, Microbiology Department 4. Procedure : Quality should be the responsibility of all persons involved in manufacturing. Each...

SOP of Control Sample Management

1.Objective :   To lay down procedure for handling of Control Sample. Also known as Retention Sample or Reserved Sample. 2. Scope : This procedure is applicable for sampling, storage, issuance and destruction of Control Sample of Key Raw material,...

SOP -List of Stamps

Objective : To lay down procedure for usage of stamps for issuance of documents by QA. Scope : This procedure is applicable to all documents, which are issued by QA to other departments. Procedure: A.Master Copy: It is the final approved / authorized copy...

SOP on Market Complaint

To lay down the procedure for handling of Market Complaints related to Intermediates &/or API.

Formats for change control , deviation & categorization of changes.

Change Control FormDownload Excerpt- 1) Do not retain this form and forward to the next after completion of review.2) Put N/A where not applicable.3) Attach an additional sheet if required as annexure.4) Please specify the details...

SOP on CAPA | Corrective Actions and Preventive Actions in Pharma Industry

Objective : To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). 2.Scope: This SOP is applicable for all Corrective Actions and Preventive Actions (CAPA) initiated for...

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