28 10, 2021

Good Practices for Data Management and Integrity

By |2021-11-08T13:49:48+00:00October 28th, 2021|Featured, Technical Article|

The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of the drug product throughout it's life cycle. The integrity of records and data can be breached at any time, by any employee – either intentionally or unintentionally.  Data integrity failure may involve omissions,

23 09, 2021

QP Declarations – Key Considerations

By |2021-10-12T17:00:38+00:00September 23rd, 2021|Featured, Technical Article|

So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines do you need to work towards? Active Pharmaceutical Ingredients or APIs must be manufactured in compliance with EU GMP and this compliance is confirmed by the QP declaration, which is submitted with the

19 08, 2021

Top 5 considerations when getting a Manufacturer’s/Importation Authorisation (MIA)

By |2021-10-13T14:08:30+00:00August 19th, 2021|Featured, Technical Article|

A Manufacturer’s/Importation Authorisation (MIA) is required if a company is involved in manufacturing and/or importation activities relating to human, veterinary or investigational medicinal product, within the EU.  The term manufacturing and/or importation includes any of the following manufacturing activities as detailed by the HPRA:  processing of a dosage form, primary packaging, secondary packaging, batch certification,

15 07, 2021

Best Practice for Virtual Audits

By |2021-10-13T14:10:38+00:00July 15th, 2021|Featured, Technical Article|

Virtual (or Remote) QP Audits have become a key tool in supplier qualification and health authority inspection programs in the Pharma industry during the pandemic. The regulatory authorities have published guidance on how they will perform their inspections by virtual/ remote audits or distant assessments during this restrictive period. There are several elements to

24 06, 2021

QTA – Best Practice Design

By |2021-10-13T14:15:09+00:00June 24th, 2021|Featured, Technical Article|

Quality Technical Agreements (QTAs) are not just a nice-to-have; there is a regulatory requirement to have them established! QTAs are established with manufacturers, suppliers and service providers to obtain written agreements of the details of activities to be provided and the associated requirements and controls. Each agreement type should be tailored to address the

19 07, 2019

GMP Requirements in the European Union

By |2019-07-19T12:43:01+00:00July 19th, 2019|Technical Article|

GMP Requirements in the EU: The contents of this article will discuss GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder compliance overview. EU requirements differ from those anywhere else in the world. To import a product into the EU you must abide by European GMP requirements. There is

18 06, 2019

The Role Of The QP In Europe

By |2019-06-18T11:45:53+00:00June 18th, 2019|Technical Article|

Why do you need a QP? According to European regulations, no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years

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