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News about GMP/cGMP

FDA: Inspectional Observations 2021 published
22.10.2021

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
15.10.2021

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
15.10.2021

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
12.10.2021

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
08.10.2021

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
01.10.2021

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
01.10.2021

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
29.09.2021

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
27.09.2021

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
27.09.2021

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
20.09.2021

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
08.09.2021

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
06.09.2021

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
26.08.2021

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
25.08.2021

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
20.08.2021

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
20.08.2021

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
06.08.2021

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
30.07.2021

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
23.07.2021

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
20.07.2021

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
20.07.2021

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
16.07.2021

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
09.07.2021

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
09.07.2021

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
08.07.2021

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
05.07.2021

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
02.07.2021

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
02.07.2021

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
24.06.2021

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
18.06.2021

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
18.06.2021

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.

Operation PANGEA XIV: Worldwide week of action against criminal online trade in medicines
11.06.2021

Once a year, operation PANGEA takes place, a globally organized action by Interpol against the online distribution of illegally imported medicines. Within this week of action, participating countries check (and close) suspicious websites and seize counterfeit medicines. In addition, this action aims to create public awareness of the issue.

EMA: Updated guidance documents on parallel distribution
10.06.2021

The European Medicines Agency, EMA, has updated its regulatory and procedural guidance documents on parallel distribution as of 9 June 2021. 

CDRH (FDA): Medical devices from Steril Milano may not be sufficiently sterilized - import ban for the U.S.
07.06.2021

The two facilities of the Italian company Steril Milano S.r.L. in Monza and Reggiolo have closed their doors since March 2021. The company, which offers a sterilization service for medical devices, is facing serious allegations of manipulation. In the meantime, Steril Milano S.r.L's certificate has been withdrawn by the responsible accreditation body.

FDA: Two new guidelines on supply chain security
04.06.2021

The FDA has finalized two guidance documents to help ensure that prescription drugs are identified and traced properly while moving through the supply chain. The documents address how to comply with the DSCSA (Drug Supply Chain Security Act) requirements.

EC: EU MDR in force along with Q&A
28.05.2021

Finally the date has come: as of 26 May 2021 the EU rules on medical devices (EU MDR) entered into force. Following a one year postponement due to COVID-19, this regulation is considered a big step forward to improve the safety and quality of medical devices. There are, however, still plenty of uncertainties for their manufacturers, but there is also a saying that every journey begins with single steps.

Switzerland, EU-MDR und a missing MRA
28.05.2021

The new European medical device regulation came into force on 26 May 2021. Parallel, a complete revision of the Medical Devices Regulation MepV was carried out in Switzerland, under the responsibility of the Swiss BAG (Federal Office of Public Health). In context of the alignment of the MepV and the KlinV-Mep with the new EU regulations MDR and IVDR on medical devices, it was also necessary to update the existing MRA (Mutual Recognition Agreement) between Switzerland and the EU. This agreement ensures barrier-free market access and joint implementation. The MRA is, in turn, part of an "overall package" of an institutional framework agreement (Insta), which has not yet been conclusively agreed on. On the contrary: Switzerland has meanwhile broken off negotiations with the EU and described them as "having failed".

Swissmedic: First agreement on close cooperation with German Federal Office of Consumer Protection and Food Safety (BVL) for veterinary medicinal products
25.05.2021

On 18 May 2021, Swissmedic and the Federal Office of Consumer Protection and Food Safety (BVL) signed a first Memorandum of Understanding on cooperation in the area of veterinary medicinal products.

FDA: Update on remote inspections guidance and future roadmap
21.05.2021

On 17 May 2021 the USFDA has released a revised version of its Q&A guidance on remote inspections. The 14-page document was originally published in August 2020 (we reported). As the pandemic still restricts most onsite inspections the FDA further clarifies general questions that came up since then.

MHRA launches its own GMDP database
21.05.2021

The British MHRA has set up a standalone MHRA-GMDP database as a new service (alpha release). This step obviously separates the UK from the EudraGMDP where the competent EU authorities publish manufacturing and wholesale approvals, GMP certificates and non-compliance reports.

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs
07.05.2021

ICH published the revised version (Step 4) of the ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents on 22 April 2021.

PIC/S: Revision of the PIC/S GMP Guide PE 009-15
29.04.2021

As announced by PIC/S on 23 April, 2021, the PIC/S GMP Guide has been revised. The changes will take effect on 1 May 2021. 

FDA:New Guidance on remote interactive inspections
16.04.2021

On 14 April 2021 the US FDA has published a new guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”. This in fact was long overdue.  It outlines 

  • how remote interactive evaluations will be requested by the FDA and 

  • how they will be conducted for the duration of the COVID-19 pandemic.

Swissmedic: Harmonization of requirements on nitrosamines with EU
16.04.2021

On 16 April 2021, Swissmedic announced that it is seeking harmonization with EU regulations regarding the handling of nitrosamine impurities.

FDA:  Patrizia Cavazzoni, M.D., to lead CDER
15.04.2021

On 12 April 2021, Dr Janet Woodcock, acting head of the US FDA, announced Dr Patrizia Cavazzoni's new role as director of CDER.

Export to UK: Exemption for Wholesalers
09.04.2021

The European Union has published the Delegated Regulation (EU) 2021/457 in its Official Journal on 17 March 2021. It amends the Delegated Regulation (VO) 2016/161 on safety features necessary for the packaging of medicinal products for human use. The amendment is to exempt the obligation for wholesalers to deactivate the unique identifier of medicinal products exported to the United Kingdom, being considered a third country now.

EMA: Q&A on the implementation of the Ireland/Northern Ireland Protocol
26.03.2021

EMA published Revision 3 of the Q&A on the Protocol on Ireland and Northern Ireland on 5 March 2021. The 11-page document contains 28 pairs of questions and answers. It is updated regularly and will be of interest to all GMP professionals who have business relationships with companies in Northern Ireland.

EMA: PDE for chlorobutanol as excipient reviewed
26.03.2021

The CMDh (EMA's Coordination Group for Mutual Recognition and Decentralized Procedures) has approached one of the EMA's Safety Working Parties (SWPs) with the following two questions regarding chlorobutanol:

  1. Can the Safety Working Party confirm that the levels of chlorobutanol commonly used in medicinal products are safe from a toxicological point of view?
  2. Is it possible to determine acceptable intake levels of chlorobutanol?

The EMA published the 15-page SWP response document to these questions on March 17, 2021.

MHRA to pick up on-site inspections by end of March
25.03.2021

The MHRA announces its return  to on-site risk based GxP inspections starting from 29 March 2021. However, it is planned to use a combined approach of both, remote and on-site inspections.

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