Internal Audits
Internal audits are a key management control activity that ensures the internal business processes are consistent. An internal audit is a form of audit process…
Design Standard Operating Procedure
How to Prepare SOP: Standard Operating Procedure (SOP) is a set of written instructions that document routine or retrospective activity. SOPs aim to achieve efficiency, quality…
Qualification: V- Model Approach, Qualification Matrix, Qualification Activity
Qualification is documented evidence that a specific equipment, facility or system is fit/ready for intended use. It is further divided into DQ, IQ, OQ &…
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 :…
Classification of Impurities
Impurities can be classified into the following categories: Organic Impurities (Process And Drug-Related) Inorganic Impurities Residual Solvents Organic Impurities : Organic impurities can arise during…
Concurrent Validation
Description: Concurrent Validation is one the approach of Process Validation where batches are released for marketing prior to approval of batches of complete validation package based on…
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…
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…
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 &…
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