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 more Topic or contents you can click or refer to my another website named as pharmapathfinder.com Deviation : Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products. … 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 →

What is Batch Packing Record (BPR) Batch Packing record is a written document of the batch from dispensing to dispatch stage which tells about the procedure and step wise instruction to be followed during the Packing of each batches. It contains actual data of the Packing and it is like a proof that batches were properly made and checked by the … Continue reading Procedure for Review of Batch Packing Record (BPR) →

What is Batch Manufacturing Record (BMR) or Batch Processing Record (BPR) : Batch manufacturing record is a written document of the batch from dispensing to Inspection stage which tells about the procedure and step wise instruction to be followed during the manufacturing of each batches. It contains actual data of the process and it is like a proof that batches were … Continue reading Procedure for Review of Batch Manufacturing Record (BMR) or Batch Processing Record (BPR) →

Procedure to be Followed as mentioned below (but not Limited to) : Before entering sterile area check temperature, humidity and differential pressures. Check that the area is kept clean at all time. Confirm the sterilization of sterile gowns and gloves by checking the indicators.Do not reuse the dress for second entry. Before touching any product … Continue reading General Rules to be followed for Working in Injectable Area in Pharmaceuticals →

CALIBRATION OF SIEVES: Calibration of Sieves Below or equal to 30# : Check the cleanliness of sieve before start the calibration. Affix “Under Calibration” label Take the plain paper and mark with pen one linear square inch in the paper with the help of calibrated standard measuring scale. Keep the marked paper below the sieve and … Continue reading Calibration Procedure for Sieves and Screens →