Pharma GMP News of the Week Aug 1 2021

Pharma GMP News of the Week: 1-August-2021

Period: July 25, 2021 to July 31, 2021

EMA published “Guideline on quality documentation for medicinal products when used with a medical device, dated 22 July 2021”

Month of publishing: July 2021

This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004.

This guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.

This guideline applies in the following cases:

• Medicinal products where the medical device and/or device part and the medicinal product form an integral product that is not reusable (hereafter called integral) and where the action of the medicinal product is principal,

• Medicinal products placed on the market by the Marketing Authorisation Holder (MAH), where the medical device is packed together with the medicinal product (hereafter called co-packaged), or

• Medicinal products, where the product information refers to a specific medical device to be used with the medicinal product, and the medical device is obtained separately by the user of the medicinal product (hereafter called referenced).


Download Guideline

EMA released “Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development” dated July 26, 2021

Date of publishing: July 26, 2021

This reflection paper identifies specific areas where the quantitative comparative evaluation of drug product quality characteristics plays an important role from the regulatory perspective. This might involve decision making processes potentially leading to marketing authorisation as well as postauthorisation decisions during drug lifecycle.

The document focusses on methodological aspects in relation to statistical data comparison approaches for pre- and post-manufacturing changes, biosimilar development, and generics’ development.

The reflection paper raises open issues from a statistical perspective, and addresses questions related to comparison objectives, sampling strategies, sources of variability and options (or limitations) for statistical inference

This document is targeted at both experts from industry and regulatory assessors. This reflection paper complements other available regulatory guidance where comparative data assessment of quality attributes is discussed for certain contexts, but also provides more detailed guidance of how to actually carry out the comparison task based on empirical sample data.

The guideline also provides protocol requirements for Quality Attributes data comparison.

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The International Council for Harmonisation (ICH) on July 27, 2021 issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.

Date of publishing: July 27, 2021

The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2 of the ICH process on 27 July 2021 and now enters the public consultation period.

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products. The principles described in this guideline may also apply to other biological/biotechnological entities.

Three different models of continuous manufacturing are described in the draft guideline:

o one includes a combination of approaches in which some unit operations operate in a batch mode while others operate in a continuous mode;

o second is where all unit operations of a drug substance or drug product manufacturing processes are integrated and operate in a continuous mode;

o third is an approach in which the drug substance and drug product unit operations are integrated across the boundary between drug substance and drug product to form a single continuous manufacturing process.

FDA has been encouraging continuous manufacturing for the past decade as a way to improve product quality, minimize product defects, and reduce drug shortages, promoting it as a more efficient process than the more antiquated batch production process. There are 10 approved continuous manufacturing applications in the US, including original applications and supplements.

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Food and Drug Administration announced revised Generic Drug User Fee Rates for Fiscal Year 2022 on Jul 28, 2021

Date of publishing: July 28, 2021

The GDUFA fees for FY 2022 announced on the Federal Register pre-publication page. The new fees will be applicable for all submissions submitted on or after October 1, 2021. The FY 2022 fees with a comparison to the FY 2021 fees is provides in the table below.

Fee categoryFees rates for FY 2021Fees rates for FY 2022% Change
Abbreviated New Drug Application (ANDA)196,868225,71214.65
Drug Master File (DMF)69,92174,9527.20
Active Pharmaceutical Ingredient (API)—Domestic41,67142,5572.13
Finished Dosage Form (FDF)—Domestic184,022195,0125.97
Contract Manufacturing Organization (CMO)—Domestic61,34165,0045.97
GDUFA Program:  
Large size operation generic drug applicant: >20 ANDAs1,542,9931,536,856-0.40
Medium size operation generic drug applicant: 6-19 ANDAs617,197614,742-0.40
Small business operation generic drug applicant: 5 or less ANDAs154,299153,686-0.40


The European Medicines Agency (EMA) on Jul 29, 2021 issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.

Date of publishing: July 29, 2021

The Reflection Paper concerns the responsibilities and activities of MAHs with respect to the European Commission’s Guide to GMP (Parts I, II, and its relevant Annexes) for medicines for human and veterinary use. It also covers the responsibilities of MAHs and Sponsors (where the Sponsor is different from the MAH) with regard to the handling of quality defects with investigational medicinal products.

The scope also extends to certain legislative provisions that have relevance to GMP, such as those stated in the GMP Directives 2003/94/EC and 91/412/EC (as amended), as well as relevant articles in Directive 2001/83/EC and Regulation (EU) 2019/6.

It also applies to holders of Registration and Traditional-use Registrations for herbal/homeopathic medicinal products.

FMD: The relevant provisions of the Falsified Medicines Directive 2011/62/EU and the related Delegated Regulations (including the Safety Features Regulation 2016/161) are also within scope of this Reflection Paper.

ATMP:  The reflection paper does not cover some of the advanced therapy medicinal product (ATMP) GMP requirements that are addressed in Part IV of the GMP guide.

GDP Responsibilities: While this Reflection Paper is not intended to address the GDP-related responsibilities that may apply to MAHs, it is considered important to highlight here that MAHs do need to understand the type of interfaces that may need to be in place with the wholesalers they employ or engage.

The main points include:

• Outsourcing and Technical Agreements
• Audits and Qualification Activities
• Communication with Manufacturing Sites (e.g. MA Dossier Information, Variations, Regulatory
Commitments, etc.)
• Product Quality Reviews
• Quality Defects, Complaints and Product Recalls
• Maintenance of Supply of Medicinal Products
• Continual Improvement Activities

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