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Express Pharma October 2025


IN THIS ISSUE

COVER STORY: Driving India's Innovation Edge

EDITOR'S NOTE: Turning the tariff tight spot into a sweet spot

INTERVIEW:

Dr Gráinne McNamara, Research Integrity/Publication Ethics Manager, S. Karger AG

Emil Alexander Byström, CEO of SpinChem AB

Ganesh Tripathy, SVP and Global Head, Sustainability & EHS, Piramal Pharma

RESEARCH:

Cell therapy’s next chapter: Industry embraces in-vivo innovation

TECHNOLOGY:

AI compass: Transforming pharma commercialization

POLICY:

Jan Vishwas Act 2025: Decriminalization and penalization of drug offences through Compounding

AYUSH:

Unani Medicine: At crossroads of tradition and modernity



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Points to Consider for Cleaning Validation [PDA TR 29]

 


PDA launched the project activities related to the PCMO program in December 2008 to help implement the scientific application of the ICH Q8, Q9 and Q10 series. The PDA Board of Directors approved this program in cooperation with the Regulatory Affairs and Quality Advisory Board, and the Biotechnology Advisory Board and Science Advisory Board of PDA.

Although there are a number of acceptable pathways to address this concept, the PCMO program follows and covers the drug product lifecycle, employing the strategic theme of process robustness within the framework of the manufacturing operations. This project focuses on Pharmaceutical Quality
Systems as an enabler of Quality Risk Management and Knowledge Management.

Using the Parenteral Drug Association’s (PDA) membership expertise, the goal of the Paradigm Change in Manufacturing Operations Project is to drive the establishment of ‘best practice’ documents and /or training events in order to assist pharmaceutical manufacturers of Investigational Medicinal Products (IMPs) and commercial products in implementing the ICH guidelines on Pharmaceutical Development (ICH Q8, Q11), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).

The PCMO program facilitates communication among the experts from industry, university and regulators as well as experts from the respective ICH Expert Working Groups and Implementation Working Group. PCMO task force members also contribute to PDA conferences and workshops on the subject.

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Analysis of 23 Elements in Wastewater by U.S. EPA Method 6020B Using ICPMS-2050




For the analysis of heavy metals in wastewater, the methods of the US Environmental Protection Agency (EPA) are considered reference for analysis worldwide. The US EPA published Method 6020B to control 23 metals in environmental water using ICP-MS. ICP-MS can analyze many elements at the ppt levels and allows for simultaneous analysis by directly introducing wastewater samples. 

 In this Application News, 23 elements in wastewater were analyzed using the ICPMS-2050. Analytical samples’ spike recovery tests and long-term stability tests were performed in accordance with the quality control (QC) requirements of the EPA Method 6020B.


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British Pharmacopoeia 2025

 


New legally enforced standards, available from 1 August 2024. All European Pharmacopoeia texts included.

Updated annually, the British Pharmacopoeia (BP) is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products.

It includes approximately 4,000 monographs which are legally enforced by the Human Medicines Regulations 2012. Where a BP monograph exists, medicinal products or active pharmaceutical ingredients sold or supplied in the UK must comply with the relevant monograph.

All monographs and requirements of the European Pharmacopoeia (Ph. Eur.) are reproduced in the BP, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond.

New for the BP 2025

The BP 2025 supersedes the BP 2024 and becomes legally effective on 1 January 2025. This edition incorporates new monographs from both the BP and Ph. Eur. along with a significant number of revised monographs.

Monographs and BPCRS:

14 new BP monographs, 32 new Ph. Eur. monographs. Including two new monographs for Paracetamol Infusion and Paracetamol Oral Solution and a new monograph for Solifenacin Oral Suspension which is accompanied by additional information on the website. This information provides a case study demonstrating how users can scale monograph methods to reduce run times and solvent usage;

105 amended BP monographs.

All monographs from the Ph. Eur. 11th edition and Ph. Eur. supplements 11.1 to 11.5.

Ph. Eur. supplements 11.6 to 11.8 included as in-year online and download product updates.

Updated references to new BPCRS included in the BP 2025 to ensure that you remain compliant.

Ensure you get the best value access to the information you need. Choose from a range of flexible licenses and formats - including full online and offline access.


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USP 2025 pdf free download (United State Pharmacopeia 48 - NF 43)

 


The United States Pharmacopeia and NF (FORMULARY National) are two separate compendia that have been combined to create USP 2025 pdf (United States Pharmacopeia 48-NF 43). It includes guidelines for medications, biologicals, chemical preparation, dosage forms, excipients, medical equipment, food supplements, and other treatments. For medications made and sold in the US, the Food and Drug Administration may impose the most recent version of the USPNF standard, which is regarded as official by USP. You may easily download pdf or learn online for free easily. Additionally, you can obtain the most recent version of the USP 2025 pdf (United States Pharmacopeia 48-NF 43).

USP 2025 pdf Monographs

The names, definitions, specifications, and other regulations pertaining to labeling, storage, and packaging are represented by monographs in pharmacopeia. In order to assist guarantee the identity, strength, quality, and purity of items, specifications include tests, processes, and acceptance criteria. Section 5, Monograph Components, contains general requirements for each monograph pieces.

Because monographs may not provide standards for all relevant characteristics, some official substances can comply with USP or NF standards but different in connection with non-standard nature.

which is relevant to its use in specific preparation. To ensure interchangeability in such circumstances, users may want to ensure equality of FUND function or determine these characteristics before use.

In this pdf format, you find a pdf of every Drug monograph like given below. Every pdf of the Monograph contain the following:-

DEFINITION
IDENTIFICATION
ASSAY

IMPURITIES
SPECIFIC TESTS
ADDITIONAL REQUIREMENTS

General Chapters

Every general chapter is assigned a number that appears in Ang brackets adjacent to the name of the chapter (e.g. chromatography)

General chapters can contain the following:

Description of tests and procedures for applications through monographs in dividual,
Specifications and Descriptions of practices & conditions for pharmaceutical compounding,
General information for interpretation of compensation requirements,
Description of general pharmaceutical storage, dispensing and packaging practice, or
General guidance for manufacturers of official substances or facial products.
When the general chapter is referenced in the monograph, the acceptance criteria can be presented after the large intestine.


Some chapters can function as an overview of Introduction to Exam or analytical techniques. They can refer other general chapters that contain techniques, procedure details, and, sometimes, acceptance criteria.


Japanese Pharmacopoeia 18th Edition


JP18th Edition [June 7, 2021, the MHLW Ministerial Notification No. 220]

General Notice - General Tests, Processes and Apparatus 

Official Monographs(A to L) 

Official Monographs(M to Z) 

Crude Drugs and Related Drugs 

Infrared Reference Spectra 

Ultraviolet-visible Reference Spectra 

General Information

JP18th Edition Errata 

JP18th Edition Supplement l 

​JP18th Edition Supplement I Errata​ 

JP18th Edition Supplement II .


The Japanese Pharmacopoeia Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. See the General Notices 5.)


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