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 &…
Category: Pharma Industry Guidelines
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 &…
Fire Extinguisher-Safety Guidelines
What is fire? Fire is the rapid oxidation of a material in the exothermic chemical process of combustion, releasing heat, light, and various reaction products. Classification of Fire : There are six classes of fire…
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,…
You must be logged in to post a comment.