Opportunities for Reducing Sampling and Testing of Starting Materials
Chapter 5 of the EC GMP Guide for the area of production was updated last year. This chapter contains concrete information about the conditions when testing and sampling of APIs and excipients can be reduced. Read more here about the sections 5.35 and 5.36 of the EU GMP Guide.
The impact of the FDA Combination Products Guidance on Nasal and Oral Inhalation Drug Products
The FDA draft guidance for combination products has a substantial impact on the development of Oral Inhalation and Nasal Drug Products (OINDPs) as it requires that the manufacturers have to be compliant not only with CGMPs for the drugs (21 CFR Parts 210 and 211) but also with the quality system (QS) regulations for devices (21 CFR Part 820). Find out more about the FDA Draft Guidance for Combination Products.
Analytical Lifecycle: USP <1210> "Statistical Tools", Analytical Target Profile and Analytical Control Strategy
The United States Pharmacopeia (USP) is currently undertaking further steps towards a comprehensive analytical lifecycle approach by publishing a draft of a new General Chapter <1210> Statistical Tools for Procedure Validation and two Stimuli Articles regarding Analytical Target Profile and Analytical Control Strategy in Pharmacopeial Forum. Read more about the life cycle concept for analytical procedures.
New Warning Letter of the FDA with the Focus on "Data Integrity"
The FDA has set the focus of its inspections on data integrity for quite some time already. The most recent Warning Letter addressed to a Chinese API manufacturer dated August 2016 clearly concentrates on the topic data integrity. Please find out more about the current FDA Warning Letter in this News.
USP revised about thirty Ophthalmic Ointment Monographs
The United States Pharmacopeia, USP, revised about 30 Ophthalmic Ointment Monographs for clarification following the revision of General Chapter <771> Ophthalmic Products - Quality tests. Read more about the revised USP Ophthalmic Ointment Monographs.
Two new FDA Warning Letters for API Manufacturers in China
In June 2016, two API manufacturers in China received a Warning Letter from the FDA. Both companies had major deficiencies regarding data integrity. For instance, manipulations were found in HPLC analyses as well as in GC analyses. You will find more information on the current FDA Warning Letters for Chongqing Lummy and Shanghai Desano here.
The World Health Organization (WHO) recently published a draft document on analytical method Validation for comment. Read more about the draft "Guidelines on Validation - Appendix 4 Analytical Method Validation".
Elaboration of New USP General Chapter <1220> - Analytical Procedure Lifecycle - announced
On June 24, 2016, the USP announced the elaboration of a new general chapter <1220> regarding life cycle management of analytical methods. Read more about the new general chapter <1220> "The Analytical Procedure Lifecycle".
FDA issues new Draft Guidance on Elemental Impurities
The recently issued FDA Guideline on Elemental Impurities as a draft describes the procedure for controlling elemental impurities for medicinal products with and without official USP monograph. Read in what cases the FDA expects the fulfilment of the requirements of the Guideline ICH Q3D respectively of the general USP Chapter <232> und <233>.
Results of a Survey on ICH Q3D "Elemental Impurities"
For most companies manufacturing APIs and pharmaceutical products, the implementation of ICH Q3D has a serious impact - as shown in a survey recently carried out by the ECA. Read more about the issues encountered by many companies regarding the assessment and control of elemental impurities and the kind of support they wish.
Five new General Chapters in the European Pharmacopoeia on Genotoxic Impurities in Pharmaceutical APIs
During the manufacture of APIs as sulfonate salts, esters of sulfonic acid may develop in undesired chemical side reactions. Recently, five new General Monographs have been included in the European Pharmacopoeia which describe how to cope with these impurities. Read more about these genotoxic impurities and the possibility to control them thanks to risk assessments.
Ph. Eur. Draft General Chapter 5.24. Chemical Imaging
A draft for a new General Chapter "5.24. Chemical Imaging" has been published for comments in Pharmeuropa 28.2. Deadline for comments is June 30, 2016. Find out more about the proposed new Ph. Eur. general chapter 5.24. Chemical Imaging.
The British authority MHRA has observed serious violations of data integrity at the Indian manufacturer Marksans Pharma Limited. Read more about the deviations with regard to data integrity.
ICH Q3D implemented in the European Pharmacopoeia: Revision of Two General Monographs with Regard to Elemental Impurities
Two general monographs of the European Pharmacopoeia have been revised and published for comment in the newest "Pharmeuropa" edition. Read more about what you will have to consider in future with regard to the control of elemental impurities in pharmaceutical preparations, APIs and excipients.
New FDA Warning Letter for Ipca Laboratories in India
In January 2016, a medicinal product and API manufacturer in India received a Warning Letter from the FDA. Manipulations of both the GC and the HPLC analysis were discovered during the review of the audit trails. Find out more about the current Ipca Laboratories FDA Warning Letter.