PART -2 Quality Agreements

Quality Agreement From a cGMP perspective, manufacturing activities are the most important element in a quality…

PART -1 Quality Agreements- “A comprehensive written agreement between parties involved in the contract manufacturing of drugs”

What Is a Quality Agreement? A quality agreement is a comprehensive written agreement between parties involved…

SOP – Procedure For Planned Modification

1.Objective: To lay down the procedure for handling of Planned Modification System. 2. Scope : This…

CEHT (Clean Equipment Hold Time Study)

Why is the CEHT important for the control of a cleaning process? Essentially the reason is…

SOP: Handling of Returned Goods

1.Objective : To lay down the procedure for handling of returned goods from distributor / customer…

SOP-Responsibility of Quality Unit

1.Objective :  To define the responsibilities of Quality Unit. 2. Scope: This procedure is applicable to…

SOP of Control Sample Management

1.Objective :   To lay down procedure for handling of Control Sample. Also known as Retention…

SOP -List of Stamps

Objective : To lay down procedure for usage of stamps for issuance of documents by QA.…

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.

Excerpt– 1) Do not retain this form and forward to the next after completion of review.2)…