Step-1 Brain Storming:What is Brain Storming :Brainstorming is a situation where a group of people meet to generate new ideas and solutions to find a conclusion for a specific problem. In this session people are able to think more freely and they suggest as many spontaneous new ideas as possible. The term was popularized by  … Continue reading Investigation tools used in Pharmaceuticals →

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 →

Who is WHO : The World Health Organization (WHO) is a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948, and is headquartered in Geneva, Switzerland. The WHO is a member of the United Nations Development Group. The constitution of the World Health Organization had been signed by 61 countries … Continue reading World Health Organization (WHO) and its Role and responsibilities →

Protocol Approval : Protocol shall be prepared by Quality Assurance or Technology Transfer department and Shall be Reviewed by Production, Quality Control, Regulatory affairs (for regulatory filling) , Qualified person or customer (if required) and Approved by Quality assurance. Before start of the activity protocol shall be approved and Training shall be imparted to the … Continue reading Process Validation Sample Protocol →

What is Process Validation: Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. Process … Continue reading Process Validation in Pharmaceuticals Manufacturing →

WHO Good Chromatography Practices Draft Guidance for the Year Feb.2019 for comments and to view next pages pl download below link............ You can also provide your comments or suggestions or request by putting mail to kopps@who.int WHO Good Chromatography Practices Draft GuidanceDownload