NEWS

EMA Publishes Draft Guideline on Complying with Clinical Trial Master File Requirements

Posted on

Is adhering to ICH Good Clinical Practice guidelines enough to ensure compliance?

The European Medicines Agency’s latest guideline says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides. These essential documents are not listed as required in ICH Good Clinical Practice guidelines. This guideline includes the following:

• Documentation that would help evaluate the trial’s conduct should be included in the file, whether they were explicitly listed in guidelines or not.

• Both paper and electronic TMF information should be verifiable with an audit trail and should protect subject confidentiality.

• TMF organization should segregate documents held by the sponsor and those held by the investigator, while avoiding duplication (i.e., separating product-development level documents such as training records, SOPs or product brochures, as well as relevant GMP information).

• Clinical master files must be archived for at least 25 years following the end of the clinical trial. For all trials that support a marketing authorization, essential documents must be retained for at least 15 years, or at least 2 years after the last approval. Subject medical files should be retained in accordance with national regulations.

Download the guidance here.

USP <1116> Microbiological Control Of Aseptic Processing Environments And Its Implications

Posted on

News from the Parenteral Drug Association (PDA): The The recently revised United States Pharmacopoeia (USP) chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments includes a thorough description, definitions and guidance on microbiological control and monitoring in aseptic processing environments.

Chapter <1116> is arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (cfu). Instead of using the microbial limits currently endorsed by aseptic guidances—which are based on cfu—<1116> proposes CRR values expressed in maximum allowed percentage of contaminated samples. The proposal is generating a broad range of discussions among pharmaceutical professionals regarding potential implications of these changes.

Read the entire article here.

Acceptability of Standards from Alternative Compendia

Posted on

Do your standards require compliance with multiple compendia? You may be able to simplify your standards testing.

The latest addition of the MAPP (Manual of Policies and Procedures) 5310.7 – Acceptability of Standards from Alternative Compendia (BP/EP/JP) published in January 2017 states that it is reasonable to accept an applicant’s proposal to use a quality standard from the BP, EP, or JP as part of the specifications for an excipient, drug substance, or drug product in the drug application, if the standard in the BP, EP, or JP is equivalent to or better than the corresponding standard in the USP/NF.

This is useful information for those responsible for marketing authorization or incoming goods control in the pharmaceutical industry.

Download the document here.

FDA Adds Device Scenarios to Final GMP Guidance for Combo Products

Posted on

In the finalized guidance on GMP requirements for combination product manufacturers, the FDA clarified how to comply with certain device requirements with compliance examples for prefilled syringes, drug-coated mesh and drug-eluting stents. This final version reiterates that combination product manufacturers have two options for compliance: satisfy all drug and device GMPs, or implement a streamlined quality system that focuses primarily on one but incorporates elements of the other GMP systems. This guidance details which GMPs are applicable to a product, general methods for how to implement them, key definitions, and how to make post-market changes to a product’s quality system. 

Read the guidance here.

Who is Responsible for Ensuring GMP Compliance?

Posted on

GMP stamps2

A recent case from Denmark demonstrated that senior management really is responsible for GMP compliance. The Danish Medicines Agency (DKMA) has now taken an action that reinforces  senior management responsibility in a very significant way: they demanded the replacement of the CEO!

It’s important that senior management understand their critical role in implementing a compliant Pharmaceutical Quality System (PQS) and in creating a good quality culture.

Share this with your senior management.

EMA Guideline on the Chemistry of Active Substances

Posted on

Active Substance

Are you preparing submissions to the EMA for marketing authorization this year?  This guideline goes into effect in July 2017 and describes the type of information required for the manufacture and control of active substances used in medicinal products for EMA marketing authorization. It replaces the “Note for guidance on chemistry of new active” (CPMP/QWP/130/96, Rev 1) and “Chemistry of active substances” (3AQ5a) and covers new and existing active substances in one guideline. 

Read more here

European Medicines Agency (EMA) Mutual Recognition Agreement (MRA)

Posted on

The EMA and FDA have agreed to recognize each other’s GMP inspections.  This Mutual Recognition Agreement goes into effect on November 1, 2017 to allow each other to:

  • rely on each other’s GMP inspections;
  • waive any requirements for batch testing of products on entry into their territories, after a transition phase;
  • share information on inspection outcomes and quality defects.

    This means that FDA inspections in the EU or EU inspections in the USA should be only performed in exceptional cases.

Read more here.

Updated GMP Inspection Process

Posted on

The FDA’s newly formed Office of Pharmaceutical Quality (OPQ) will update its GMP inspections process to add risk-based factors to give sites with higher risk more attention and reward sites that exceed basic compliance.

This New Inspection Protocol Project (NIPP) changes GMP inspections by standardizing data gathering during inspections, using a question-answer based reports with a semi-quantitative scoring to allow for comparisons within and between sites, and a common inspection report structure.

The NIPP program is expected to start in 2017 as a pilot program to collect feedback and experience from the inspectors before it is formally implemented. As FDA inspections become more transparent and semi-quantitative, it is bound to be mutually beneficial to both FDA and the industry. The program was one of the 5 areas of priority for OPQ.

 

Proposed New USP General Chapter: The Analytical Procedure Lifecycle

Posted on

ABSTRACT (from the document): An analytical procedure must be demonstrated to be fit for its intended purpose. It is useful to consider the entire lifecycle of an analytical procedure, i.e., its design and development, qualification, and continued verification. The current concepts of validation, verification, and transfer of procedures address portions of the lifecycle but do not consider it holistically. The purpose of this proposed new chapter is to more fully address the entire procedure lifecycle and define concepts that may be useful. This approach is consistent with the concept of quality by design (QbD) as described in International Council for Harmonisation (ICH) Q8-R2, Q9, Q10, and Q11. The lifecycle approach can potentially be applied to all procedures, although the level of effort should be consistent with the complexity and criticality of the procedure.

FDA Guidance for Pharmaceutical CMO Quality Agreements

Posted on

Quality agreements are critical to ensure you and your contract manufacturer define each other’s roles and responsibilities with respect to quality. On November 22, 2016, the FDA released the finalized guidelines that specify what should go into quality agreements between pharmaceutical companies and outsourced contract manufacturers.

This guidance applies to commercial manufacturing for human drugs, veterinary drugs, certain combination products, biological and biotechnology products, finished products, APIs, drug substances, in-process materials, and drug constituents of combination drug/device products.

It does not apply to Type A medicated articles and medicated feed, medical devices, dietary supplements, or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of the Public Health Service Act and 21 CFR part 1271.

Download the guidance here.