Procedure to be followed (But Not Limited to ): Access to the Manufacturing Area is restricted to Authorized personnel onlyAll personnel entering the Drug Product Facility shall follow the gowning Procedure mentioned in the SOP   Procedure for Entry and Exit from Change  room to Process and Packaging Area.Before entering the process area, the personnel shall … Continue reading Processing Controls to be followed During Manufacturing of Drug Products →

On the event of Power Failure : Once the production is stopped due to power failure during manufacturing and  Packing Process, switch off the equipment's immediately after power failure which are having moving parts and directly connected to main supply. Record the stoppage time in the respective record wherever required. If power failure is less … Continue reading Handling of Products during Power stoppage in Manufacturing and Packing Process →

What is SMF : A Site Master File (SMF) is a document that describes the structure of the organization which includes the site, the manufacturing activities carried out, the facility and premises, number of employee with their Qualification, Production system, Quality Control System and also details of the quality management system which are in place. … Continue reading Preparation of Site Master File (SMF) →

What is Form 483 : Form FDA 483 Inspectional observations is a form used by the FDA to document and communicate concerns observed during inspections of the site or firm or organization. It is also reffered to as Form 483. Refer https://pharmaceuticalupdates.com/2019/03/02/united-state-food-and-drug-administration-usfda-and-form-483-and-warning-letters-at-a-glance/ Most of 483 observations in FDA inspections are repeated frequently in different pharmaceutical … Continue reading Most common 483s Observation in USFDA →

What is APQR/PQR : Annual product quality review is regular periodic quality reviews of all licensed commercial medicinal products which are conducted with the objective of verifying the consistency of the existing process, parameters, the rightness of current specification for both starting materials and finished products to highlight any trend, Deviation, change control, Market complaints … Continue reading Annual Product Quality Review (APQR/PQR) in Pharmaceuticals →