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 →

Line Clearance What is Line Clearance : Line clearance is a process which provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or left over of previous processing’s before proceeding for next process. Quality assurance has to provide Line clearance before the start of … Continue reading Line Clearance Procedure in Pharmaceuticals →

What is Standard Operating Procedure : It is an authorized written document which describes the step by step instructions requirements for Quality system, performing operations, non specific to any product, process or material. It provides detailed procedure about systems applicable to various operation e.g. Equipment’s / Instrument’s / System’s Operation / Cleaning / Maintenance. Everybody … Continue reading Standard Operating Procedure (SOP) of Standard Operating Procedure (SOP) →

Fumigation and fogging are two methods which are commonly used in pharmaceutical (Both Sterile & Non sterile) companies to control the microbial contamination in controlled area. But now a day’s fumigation with formaldehyde solution and potassium permanganate is banned by different regulatory agencies in pharmaceutical companies. The Photo of Fogger Instrument.......... What is Fumigation : … Continue reading Difference between Fumigation and Fogging in Pharmaceuticals and other Areas →

WHO IS CDSCO : The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines agency of the European Union, the Japan, the Foods & Drugs Administration of the United states and the Medicines and Health care products Regulatory agency of the united Kingdom. The Central Drugs Standard Control Organization (CDSCO) is the Central Drug … Continue reading Central Drugs Standard Control Organization (CDSCO) and Its Function →

In the earlier blog we have discussed about Falsified Medicines Directive (FMD) of Europe & Track & Trace System of USA . Below are the difference between these two.......... Related Topic https://pharmaceuticalindustrydotblog.wordpress.com/2019/01/27/importance-of-track-and-trace-system-for-pharmaceutical-packaging/ Related Topic : https://pharmaceuticalindustrydotblog.wordpress.com/2018/12/27/what-is-fmd-falsified-medicines-directive-in-pharmaceuticals-packing/ FMD vs Track & Trace