Good manufacturing practices for Pharmaceutical products

current Good manufacturing practices for pharmaceutical products (cGMP) As per WHO 1.1 Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent …

Good manufacturing practices for Pharmaceutical products Read More »

SOP on Handling of Incidents and Deviations

SOP on Handling of Incidents and Deviations PROCEDURE: Definition: Departure from an approved instruction or established standard. Deviation shall be lodged when deviation from the written procedure is observed / taken from following documents (but not limited to): SOP BMR BPR STP SPEC. No deviation is permitted from Pharmacopoeia and other Regulatory specifications. However additional …

SOP on Handling of Incidents and Deviations Read More »

Drug Regulatory Affairs – CTD

Drug Regulatory Affairs – CTD. Drug Regulatory Affairs in Pharma Industry plays important role as all departments of Pharma product Manufacturing Like Quality Assurance, Quality Control, Production, Microbiology also same as Formulation & Development Department & Analytical Development Department. Drug Regulatory Affairs comes in last stage of Product Preparation & distribution like after complete & successful …

Drug Regulatory Affairs – CTD Read More »

SOP on Maintenance and Preparation of Anaerobic Culture Suspension.

SOP on Maintenance and Preparation of Anaerobic Culture Suspension ( Clostridium Sporogenes ). This procedure is for Maintenance & preparation of culture suspension for anaerobic microorganisms in Microbiology Department.  it includes maintenance of culture & preparation of culture suspension as per Culture Dilution Method. PROCEDURE: Maintenance: Prepare Nutrient Agar as per Media preparation SOP Pour 5 mL …

SOP on Maintenance and Preparation of Anaerobic Culture Suspension. Read More »

SOP on Change Control

SOP on Change control PROCEDURE: TYPES OF CHANGE CONTROL: DOCUMENT CHANGE CONTROL (DC) : Initiation of a document or modification of approved documents including but not limited to Master Batch Records (MFR/ BMR/ BPR), standard Operating specifications, Method of Analysis, format / Labels, Qualification / Validation Protocols, Stability Protocol, Validation Master Plan, Policies and Guidelines, …

SOP on Change Control Read More »

Training of employees

Training of employees PROCEDURE:                   Every employee of the organisation shall first undergo an Induction Training and then to be trained on his / her area of operation prior to start the work. Induction Training shall also include a visit and understanding of works done in Departments other than their own. An Induction Training Record …

Training of employees Read More »

Microbiology.

Microbiology. Microbiology is the crucial section of Sterile Pharmaceutical products, it is very Important in Non- Sterile Products. Microbiology section is divided in following sections;  Antimicrobial Effectiveness Testing.(USP <51>)(Ph. Eur. general texts 5.1.3)  Microbial Examination of Non-Sterile Products.( USP <61>,<62>)(Ph. Eur. method 2.6.13./2.6.12) Sterility Testing.(USP <71>),(Ph. Eur. method 2.6.1) Bacterial Endotoxin Testing.( USP <85>) Particulate …

Microbiology. Read More »