FDA Draft Guidance Quality Consideration for Continuous ManufacturingDownload

What is Yellow Card Scheme in UK : The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The Yellow Card Scheme is essential in helping the MHRA to monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who … Continue reading Yellow Card in Medicines and Healthcare Products Regulatory Agency (MHRA) and its Reporting details at a Glance →

Who is MHRA : The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom (UK) which is responsible for ensuring that medicines and medical devices work and are acceptably safe. When MHRA Formed : MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency … Continue reading Medicines and Healthcare products Regulatory Agency (MHRA) and its Role and Responsibility →

Who is USFDA : The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency. The FDA is led by the Commissioner of Food and … Continue reading United State Food and Drug Administration (USFDA) and Form 483 and Warning Letters at a Glance →

Procedure : Intimation / Conformation of Inspection : Intimation for the inspection from Regulatory Authority shall be received by Corporate Office and shall be communicated to Unit Head and or Quality Head of the respective site or location. The confirmation for the inspection programme with Regulatory Authorities should be done by Corporate Quality Assurance. The itinerary … Continue reading Audit of Pharmaceutical Plant By External Auditors →

For IDFC First Bank Life time free credit card can click https://bitlii.cc/OP/b20lxyuvxti For Axis Bank Credit card can click https://bitlii.cc/OP/b20lxyvibcc For AU Small Finance Bank Credit card can click https://bitlii.cc/OP/b20lxyvk18d For HSBC Bank Credit card can https://bitlii.cc/OP/b20lxyxuknn For IndusInd Bank Credit card can click https://bitlii.cc/OP/b20lxyxv27u For SBI Bank Credit card can click https://bitlii.cc/OP/b20lxyxw3dw For Kotak … Continue reading Procedure for Handling of Deviations →

The following terms and definitions are provided to assist the reader in using this guidance Documentation. Batch Number  : A distinctive combination of numbers or letters from which the complete history of  the manufacture, processing, packaging, coding and distribution of a batch can be determined. Documentation that provides the history of a batch from the raw … Continue reading Definition used in Pharmaceuticals →

What is Disintegration: It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (environmental) for a group of tablets/capsules to disintegrate into particles. Disintegration is to be Performed to determine whether tablets or capsules disintegrate … Continue reading Disintegration Test Specification and Calibration →

For more Topic or contents you can click or refer to my another website named as pharmapathfinder.com What is Friability Test of Tablet ??? Friability is defined as the percentage of weight loss of powder from the surface of the tablets due to mechanical action and the test is performed to measure the weight loss … Continue reading Tablet Friability Test Specification and Calibration →

Objectives : Review measures to ensure Good Sanitation in: Premises and Personnel Equipment and Apparatus Processes, Materials and Containers 2. To review measures to ensure Good Personal Hygiene Scope : High level of Sanitation and Hygiene practiced – in every aspect of  Manufacturing.  It covers: Personnel Premises Equipment and Apparatus Production Materials and Containers Products for … Continue reading Health and Hygiene in Pharmaceuticals →