Authorjulian.koster@pcs-nl.com

GMP & GDP Software – Computerized Systems Validation Approach

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Why is GMP validation important? alidation is performed to test a computerized system against the predefined requirements. These requirements are created by regulatory bodies such as the EU and U.S. FDA. The company doing the validation can formulate additional requirements. The leading regulatory requirements (EudraLex Volume 4 Part 1 Annex 11 & U.S. FDA 21 CFR Part 11) are mainly focused on...

HVAC systems in pharma – part 1

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In this two-part blog we’re discussing air handling systems in pharma; also referred to as HVAC systems. HVAC is an abbreviation for; heating, ventilation and air conditioning. A few basic concepts will be touched upon. These basic concepts include; The need and reason for pharmaceutical HVAC systemsTechnical requirements for HVAC systemsDifferent types of HVAC systemsQualification and...

responding to inspection observations

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You’ve hosted a GMP regulatory inspection. After a few weeks you receive the preliminary GMP inspection report, now it’s time to respond in a manner that makes the regulatory authority confident that you will get your things in order. Besides drafting proper CAPAs we have some tips to make sure that you respond to the inspection report in a way that instills confidence. Basic GMP...

detail level of a SOP FOR Cleaning and Disinfection

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The cleaning and disinfection of GMP production area’s is a tricky subject when you’re setting up your GMP Quality Management System. Each company has it’s own level of detail. We’ve seen SOP’s with thirty pages and SOPs with five pages. There is no right or wrong. If your SOP is unidirectional, well-written and follows Good Writing Practices, it may very well be...

qualified person training module 1

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Are you a Qualified Person? Or a (young) professional in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance or Regulatory Affairs? Dealing with complex quality systems? During these four days of training, you will explore the role and responsibilities of the Qualified Person in the pharmaceutical industry and hospital...

Practical Pointers for Aseptic Facilities (cleanroom qualification)

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When we’re building new facilities clients often ask us; how do I qualify my cleanroom? What are the exact zoning requirements and what specification should my design meet? If you’re facing such questions or if you simply want to benchmark your own qualification against the GMP’s then please download our practical pointers for aseptic facilities document. This document was part...

Contamination control

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One of the important topics in the pharmaceutical and biotech industry or actually in the entire production industry is contamination control.Since our customers are patients, we need to be extra careful and ensure that these vulnerable customers do not have contaminants in their medication. Companies should do their utmost best to keep contamination contained. Which means that a contaminant...

Document revision in PCS intelligence

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hen a company decides to implement an EQMS, it has to make important decisions. One of these decisions is the level of digitalization. Some companies choose to use an EQMS to control printed documents. Other companies choose to only digitalize certain components, while others decide to completely digitalize the entire company. One of the biggest advantages of PCS Intelligence is the level of...

Equipment qualification

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The qualification of equipment is a GMP requirement. Qualification is the documented evidence of the verification that a pharmaceutical machine meets the pre-determined requirements. The definition varies per guideline. For more information you can check the following documents; Annex 15 of Eudralex Volume 4 – LIFE CYCLE APPROACHEMA Process Validation Guideline for Finished Products ...

Validation PCS Intelligence

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One of the first questions we receive when speaking with clients is whether the system is validated or not. Understandably so, because validation is one of the most important aspects of a computer system for the pharmaceutical market. Software that is not validated has no place in a pharmaceutical company.   Validating computer software is an important but labor-intensive task. We at...