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News about GMP/cGMP

Amendment of Delegated Regulation (EU) on Safety Features

Already in March last year, an adaption of the Delegated Regulation (EU) 2016/161 on safety features allowed a temporary derogation of the obligation for wholesalers to deactivate the individual identifier (IE) of medicinal products exported to the UK - as a third country (we reported). This exemption was granted for the year 2021.

EC: Updated Q&A on Safety Features, Version 19

The European Commission published Version 19 of the Q&A on safety features for medicinal products in late December 2021.

What's new?

  • Question 1.29: Do the unique identifiers of reference and retention samples taken from stock in compliance with Annex 19 of the EU GMP Guidelines5 and uploaded to the EMVS have to be decommissioned? If yes, to what status?
    Answer: Yes, if a sample of a batch is taken as reference or retention sample after uploading in EMVS, it should be decommissioned as "sample". If a sample is taken voluntarily by a wholesaler that fall outside the scope of Annex 19, they should be decommissioned as "destroyed".
EMA: ICH Q9 on Quality Risk Management in Step 2b

On 16 December 2021, EMA published the ICH Q9 draft document on Quality Risk Management (QRM) in step 2b. The draft provides important additional guidance on four specific areas:

  • the levels of subjectivity in risk assessments and in QRM outputs,
  • the product availability risks,
  • the lack of understanding as to what constitutes formality in QRM work, and
  • the lack of clarity on risk-based decision-making.
ICMRA: Authorities summarise global experiences on remote inspections

The International Coalition of Medicines Regulatory Authorities, ICMRA, has published a comprehensive reflection paper on experiences with different inspection models to maintain GCP and GMP inspections during the covid pandemic. The working group responsible for the paper was composed of representatives from various regulatory agencies around the world. To anticipate the group's conclusion: Remote inspections enable minimal regulatory oversight during the pandemic but will not be able to replace on-site inspections in the future.

TGA: Hybrid and remote GMP-inspections

The Australian authority TGA has published a revision of the guideline on licenses and certification "Guidance on Australian manufacturing licenses and overseas good manufacturing practice (GMP) certification" on 1 December 2021. The revision relates to an expansion of possible inspection types as well as the scheduling of the inspection for licensing procedures.

EMA: Overview on comments on drug device guidance

On 6 December 2021, the EMA published all stakeholder comments received on the Guideline on quality documentation for medicinal products when used with a medical device (we reported). It will enter into force on 1 January 2022. Comments were received from 36 different stakeholders from all over Europe, including e.g., MedTech Europe, Medicines for Europe or the Parenteral Drug Association, PDA.

Swissmedic: Registration required for medical product manufacturers

To ensure market surveillance of medical devices, manufacturers, authorized representatives and importers based in Switzerland must register with Swissmedic within three months of first placing a product on the market. This was revealed in a Swissmedic announcement in late November.
After the applicants have undergone the process, they will be assigned an individual Swiss identification number, the Swiss Single Registration Number (CHRN).

EU: Implementing regulation on EUDAMED published

On 26 November 2021, the European Commission issued the Implementing Regulation (EU) 2021/2078 on the European Database for Medical Devices, Eudamed. The document provides a legally binding framework for all users.

USP: New General Chapter <1469> on Nitrosamine Impurities

As of 2 December 2021, the new general chapter <1469> on nitrosamine impurities has been added to the United States Pharmacopeia (USP). With this, it is intended to support both pharmaceutical manufacturers and authorities in assessing the presence of nitrosamines and implementing appropriate control strategies and analytical procedures. The chapter is aligned with the current FDA guidances.

EMA: Revision of Q&A on pre-authorisation of centralised procedures

The European Medicines Agency has revised its 142-page document European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. The publication of 22 November 2021 includes the adjustments already made in October, as well as an update to paragraph 2.9 on the procedural structure of application from November. All changes to the document are marked with a corresponding date reference and concern section 2 "Steps prior to submitting the application".

EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines

The European Medicines Agency (EMA) has published a 13-page Q&A including 87 questions and answers from a webinar held on the topic of integrating EudraGMDP and OMS (Organisation Management Services) into the new regulatory framework for veterinary medicines.

FDA: President Biden nominates Dr. Robert Califf for FDA commissioner

Finally, the long-awaited nomination for the next FDA commissioner is here. President Biden has nominated Dr. Robert Califf, a clinical trial expert and founding director of the Duke Clinical Research Institute.

EU GMP Guide: New concept papers for revision of Annex 4 and Annex 5 for VMPs

The European Medicines Agency has published two new concept papers for Annex 4 and Annex 5 for veterinary medicinal products on 11 November 2021:

  • Concept paper on the revision of annex 4 of the guidelines on good manufacturing practice – manufacture of veterinary medicinal products other than immunologicals
  • Concept paper on the revision of annex 5 of the guidelines on good manufacturing practice for medicinal products – manufacture of immunological veterinary medicinal products
EC: Mandate for strategic approach on pharmaceuticals and environment

The European Commission has tasked its ad-hoc working group (WG) on pharmaceuticals in the environment with drafting a concept paper on the regulatory framework. The WG formed in 2020, is joined by the following Member States: Austria, The Czech Republic, Finland, France, Germany, Ireland, The Netherlands, Slovenia, Spain, Sweden, Poland, Romania, Italy and the European Medicines Agency (EMA).

TGA continues use of remote inspections

The Australian Therapeutic Goods Administration, TGA,  updated its GMP approach to overseas manufacturers of medicines and biologicals on 1 November 2021. With the COVID-pandemic still being an issue, TGA named remote inspections the only currently available option for certification applications.

EU: Procedures on Inspections and Exchange of Information in new Version 18

The European Commission has revised and restructured the Compilation of Community Procedures on Inspections and Exchange of Information. In addition to new content and editorial adjustments, the 295-page document has been divided into a Part I including procedural topics and a Part II containing interpretation documents and templates. The documents were last updated in 2014.

FDA/CDRH: Proposed Guidances for FY 2022

The FDA’s Center for Devices and Radiological Health (CDRH) has published its lists with guidance documents intended to be published next year. At this stage CDRH is interested in receiving external feedback on whether the listed documents should be revised or withdrawn.

US, Canada, and UK issue joint principles on Good Machine Learning Practice

The US FDA, Health Canada, and the British regulatory agency MHRA have jointly released 10 guiding principles to support the development of Good Machine Learning Practice (GMLP). As a basic framework it should help to promote safe, effective, and high-quality medical devices, while using AI (artificial intelligence) and ML (machine learning).

FDA: Inspectional Observations 2021 published

The FDA’s Office of Regulatory Affairs (ORA), responsible for inspections and other field activities, has released its summary on inspectional observations listed on FDA Forms 483 from October 2020 to September 2021.

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.

EC: Proposal for progressive introduction of IVDR

On 14 October 2021, the European Commission has proposed a “progressive roll-out” of the upcoming In Vitro Diagnostic Medical Devices Regulation, IVDR. The reason given for that is to prevent disruption in the supply of those essential healthcare products that fall under it, as well as a serious shortage of notified body capacity. The IVDR was planned to apply as of 26 May 2022.

EMA: Q&A on Nitrosamines updated

The European Medicines Agency EMA has further updated its Q&A on nitrosamine impurities. The document is intended to support marketing authorization holders of human medicinal products and considers the latest regulatory requirements (we reported).

PIC/S: China applies for PIC/S accession

The Chinese NMPA applied for PIC/S pre-accession on 24 September 2021. Although this stage is a voluntary assessment process, gaps are identified between PIC/S membership requirements and the system used by the regulatory agency that is interested.

EDQM: Mutagenic azido impurities in Losartan

The European Directorate for the Quality of Medicines, EDQM, has identified another azido impurity which was tested positive in a mutagenic evaluation. So far, it has only been found in "Losartan potassium".

EMA: Validity of GMP and GDP certificates extended

The European medicines regulatory network has announced the automatically applied extension of the validity of GMP and GDP certificates for sites in the EEA (European Economic Area) until the end of 2022, unless there are restrictions on the validity period stated in the clarifying remarks of the certificate. This extension also applies to time-limited manufacturing and import and wholesale authorisations.

EUDRAGMDP: EMA with important information for all users

As communicated by the EMA, the EUDRAGMDP database will be „merged“ with EMA’s Organisation Management Service (OMS). This is an important change to be aware of for all manufacturers, importers and distributors of human and veterinary medicines whose information is recorded in EUDRAGMDP.

FDA: Revised Q&A on Biosimilar Development

On 17 September 2021, the US FDA released the revised Q&A Guidance on Biosimilar Development and the BPCI Act. The 28-page document provides rapid, development-related guidance to biosimilar and interchangeable biosimilar sponsors and other stakeholders on discrete issues.

EU: Amendment to Delegated Regulation (EU) 2016/161 on safety features

On 21 September 2021, an amendment to Delegated Regulation (EU) 2016/161 was published in the Official Journal of the European Union. Article 47 "Evaluation of notifications" was adapted and in Annex I, containing the list of medicinal products exempted from the obligation to bear the safety features, a new entry has been added.

Final draft of new USP chapter <1083> Supplier Qualification

On September 15, the U.S. Pharmacopeia USP published the final draft of the chapter <1083> Supplier Qualification.

EDQM: New chapter on balances in the European Pharmacopoeia

As of July 2021, the European Pharmacopoeia (Ph. Eur.) now contains chapter 2.1.7 "Balances for analytical purposes". It was included as an addition to section 2.1 Apparatus and defines the requirements placed on the "balance" tool in an analytical procedure.

EDQM: Guidance for electronic submissions of CEP applications revised

In July 2021, EDQM published a revised version of the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" (PA/PHCEP (09) 108). This guidance includes the current requirements for how an application for Certificates of Suitability must be conducted in eCTD format.

MDCG: Guidance on repackaging and relabeling processes of devices

This month, the Medical Devices Coordinating Group of the European Commission, MDCG, published a 7-page guideline for notified bodies, distributors, and importers of medical devices. It should provide a basis for the certification of quality management systems (QMS) related to repackaging and relabeling processes of medical devices according to MDR and IVDR.

WHO publishes draft documents on medicinal gases, IPs and development facilities

The WHO has published three GMP-relevant draft documents in recent weeks:

  • WHO good manufacturing practices for investigational products
  • WHO good manufacturing practices for medicinal gases, Rev.1
  • WHO good practices for research and development facilities of pharmaceutical products
EMA: Draft Guidance on SmPC for ATMPs with Gene-modified Cells

The European Medicines Agency (EMA) has issued a 31-page draft guideline describing the information to be included in the Summary of Product Characteristics (SmPC), labelling and package leaflet for Advanced Therapy Medicinal Products (ATMPs) that contain genetically modified cells.

EMA: Guideline on quality documentation for combination products

Following a two-years drafting process the CHMP of the EMA has adopted the final guideline on quality documentation for medicinal products when used with a medical device on July 22, 2021.

EMA: Paper on GMP Responsibilities and MAHs

On 23 July 2021, EMA has finalized its reflection paper on GMP-related responsibilities and marketing authorisation holder companies (MAHs). As various tasks are spread over different chapters and annexes of the EU GMP Guide and various directives, the paper now summarizes them in a single 29-page document. This is to provide clarity on which responsibilities are to be considered and what they signify for MAHs at a practical level.

ICH: ICH-Q13 Draft on Continuous Manufacturing released

On 27 July 2021, ICH published the anticipated draft of its Q13 Guideline on Continuous Manufacturing of Drug Substances & Drug Products. In Stage 2 of the ICH process the 44-page document has thus been released for public commentation.

The guideline is intended to provide "scientific and legal considerations for the design, implementation, operation and lifecycle management of continuous manufacturing (CM)".

FDA: Push for more authority on device shortages

As part of the annual budget planning acting FDA Commissioner Janet Woodcock has addressed the problem of weaknesses in the medical devices supply chain and its overall dependence on foreign medical devices.

PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19

PIC/S published a new guidance COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) which entered into force on 15 July 2021.

The guidance is addressed to inspectors and covers the actions to be taken during the planning phase of an inspection, in consultation with the site to be inspected.

PIC/S: Final Recommentation Document on Risk-Based Change Management

On 15 July 2021 the PIC/S recommendation document How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management (PI 054-1) came into force. The document provides practical guidance and covers all relevant steps in change management process – change proposal, change assessment, change planning and implementation, change review and effectiveness checks.

EC: Kiwa Cermet Italia S.P.A. becomes 21st Notified Body

The European Commission announced on 14 July 2021, that the Italian company Kiwa Cermet Italia S.P.A. has been appointed as the 21st Notified Body under the EU Medical Devices Regulation (MDR) 2017/745. It has been assigned the number 0476 in the EC's Nando database.

PIC/S: Final guideline on Data Management and Integrity

After five years of drafting, PIC/S has now published the final version of a new guideline on data integrity, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). The document has already been applied in practice on a trial basis during this time and has been modified twice.

EMA: Updated Q&A on Drug-Device-Combination Products under new MDR/IVDR

EMA has updated its Q&A document on drug-device combination products by end of June 2021. It includes the current requirements under the Medical Devices Regulation (MDR), which entered into force on 26 May 2021. Marketing authorisation holders of combination products are provided with detailed information on all current adjustments.

EMA: Revised Q&A on assessment of nitrosamine impurities

On 2 July 2021 the European Medicines Agency has released a revised version of the 17-pages Q&A to aid marketing authorisation holders to assess their risk for nitrosamine impurities. The revision affects questions 3 and 10:

  • For the ‘call for review’ for chemically synthesised and biological medicinal products, when and how should MAHs report steps 1 and 2 to competent authorities? (Q&A 3)

  • Which limits apply for nitrosamines in medicinal products? (Q&A 10).

Swissmedic: Information sheet on the Swiss Authorised Representative (CH-REP) for medical devices

The aborted negotiations between Switzerland and the EU on the institutional framework agreement (we reported) are casting their shadow: new regulations are needed to ensure the safe supply of medical devices within Switzerland. However, not only Swiss manufacturers are affected. Medical device manufacturers who are not domiciled in Switzerland but who place products on the market there must also mandate an authorized representative in Switzerland.

IVDR: Netherlands' DEKRA designated fifth Notified Body

The Netherlands’ DEKRA Certification B.V. was named the fifth notified body under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in June 2021. Dekra Certification B.V. is also a designated notified body under the MDR.

EC:Updated Version 18B of Q&A on Safety Features

The European Commission published version 18B of the Q&A on safety features for medicinal products in late May 2021. In the 34-page document, question 1.14 "Are there mandatory specifications for tamper evidence?" was updated.

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S has started the consultation process for the adoption of Annex 16 of the EU GMP Guide. It is a very important step towards international harmonisation of GMP requirements.

EMA: Annual Report 2020 published

As every year, the EMA now publishes its report for 2020, in which it outlines achievements, decisions and objectives of the year.

FDA presents first global forum for generics

In early June, the FDA unveiled the Generic Drug Cluster, the first forum for leading regulatory authorities to address the global development of generic drugs.

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