Year: 2018

What is Data Integrity In Pharmaceutical Industry…???

What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, …

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What is Minimum Requirements of EU Agencies from Production section of Manufacturing site.?

Minimum Requirements in  Production section  for EU authorized Human Pharmaceutical products manufacturing site as per Eudralex Volume 4  part 1 Chapter 5: Production.    Principle Production operations must follow clearly defined procedures; they must comply with the principles of Good Manufacturing Practice in order to obtain products of the requisite quality and be in accordance with the relevant …

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Minimum Requirements of Premises and Equipment as per EU Guideline before going for EU Regulatory Audit.

Minimum Requirements of EU for Premises and Equipment in Human Pharmaceutical products Manufacturing site  as per EU Guideline before going for EU Regulatory Audit.   PRINCIPLE Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk …

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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 …

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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 …

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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 …

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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 …

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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, …

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