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.
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.
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.
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.）
Rules to Amend the Cosmetics Rules, 2020
The Ministry of Health and Family Welfare has notified the Cosmetics (Amendment) Rules, 2025, making several key changes to the Cosmetics Rules, 2020, including clarification on expiry labelling, redefining regulatory terminology, updated recordkeeping norms, and introducing a new provision for licence cancellation or suspension.
The notification, published as G.S.R. 513(E) in the Gazette of India on 29th July 2025, states:
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“Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules to amend the Cosmetics Rules, 2020.”
One of the significant changes is the insertion of a clear definition regarding expiry labels:
“For the purposes of this clause, the expression ‘use before’ means, use before the first day of a month mentioned on label and the expression ‘date of expiry’ mean the cosmetic expires on the last day of the month.”
The amendment also replaces the term “controlling officer” with “Controlling Authority” across multiple rules including Rules 6, 9, and 31(2). Further, Rule 7 has been substituted entirely to clarify that:
“The Government Analyst appointed under section 20 of the Act (23 of 1940) shall be the Government Analyst for the purposes of these rules.”
A major structural change has been introduced with the insertion of Rule 31A titled “Cancellation or suspension of licence.” It empowers the State Licensing Authority to cancel or suspend a licence in case of violations, stating:
“If a licensee fails to comply with any of the conditions of license or with any provision of the Act or the rules made thereunder, the State Licensing Authority may... cancel a licence issued under these rules or suspend it... wholly or in respect of some of the substances to which it relates.”
It also allows for an appeal:
“A licensee whose licence has been suspended or cancelled, may, within a period of ninety days... appeal to the State Government... and the order... shall be final.”
In another key compliance update, new clauses under Rule 26 mandate that:
“The licensee shall keep record of the details of each batch of cosmetic manufactured and of the raw materials used therein... and such records shall be retained for a period of three years or six months after expiry of the batch whichever is later.”
“The licensee shall test each batch or lot of the raw materials used... and also each batch of final product... and shall maintain records... retained for a period of three years or six months after expiry...”
However, these provisions exempt soap manufacturers:
“Provided that clauses (f) and (h) shall not apply to the manufacture of soap... approved by the Licensing Authority.”
Among other changes:
1. Rule 11 now designates the Central Drugs Laboratory to also serve as the Central Cosmetics Laboratory for analysis and appellate functions.
2. In cases of export, Rule 34(10) has been revised to clarify that:
“The label on package or container of cosmetic shall comply with the law of the country to which the cosmetic is to be exported... where a cosmetic is required by the consignee to be not labeled with the name and address of the manufacturer, the label... shall bear a code number as approved by the State Licensing Authority.”
Several terminologies across the rules have also been aligned—replacing “licence” with “approval,” and “licensed premises” with “approved premises,” in relevant provisions, including Rules 60, 61, and 62. Additionally, courier-based provisions in Rule 49 have been omitted.
The notification concludes:
“The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide notification number G.S.R.763 (E), dated the 15th December, 2020.”
Express Pharma Digital Issue August 2025 - Revolutions In Injectables
IN THIS ISSUE COVER STORY
Revolutions In Injectables
EDITOR'S NOTE
Walking the talk on ESG, workplace safety
INTERVIEW
Dr Satish Wagh, Chairman, CHEMEXCIL, and founder, Supriya Lifescience
MARKET
Startups: India’s next big bet on pharma innovation?
Pretty risky: India's wellness boom and the missing rulebook
TECHNOLOGY
Digital twins: Revolutionizing vaccine trial site procurement in developing countries
STRATEGY
How patient suites are reshaping the future of clinical trials
RESEARCH
Can stem cell therapy cure diabetes?
POST EVENT
IIHMR University's annual convocation 2025 felicitates 423 graduates, highlights global recognition and academic excellence
Martindale: The Complete Drug Reference 38th Edition
Martindale: The Complete Drug Reference provides unbiased, evaluated information on drugs and medicines in use around the world. It is updated by an experienced team of pharmacists and life scientists who use their professional expertise to provide an unbiased and evaluated digest of the available literature, selecting the most clinically relevant and appropriate information from reliable published sources. This 38th edition of Martindale has been completely redesigned to ensure ease of use and greatly improved readability. This latest edition contains over 6000 monographs, including 200 new monographs, on drugs and ancillary substances such as herbals, pharmaceutical excipients, and toxins and poisons. There are over 180,000 preparations giving details of preparation name, manufacturer, ingredients, and uses for proprietary preparations and now covering over 40 countries and regions, including China. The content is evidence-based and extensively referenced with links to the published literature.
- ISBN-10 : 0857111396
- ISBN-13 : 978-0857111395
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance.
This latest version describes new variations in the European Pharmacopoeia for the manufacture of Water for Injection by methods other than distillation. Additional changes include discussions on the global harmonization of water quality attributes, comprehensive pretreatment design, rapid microbial monitoring, ozone for ambient sanitization, and membrane technologies. This version is aligned with the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition).
The Guide was written by a global team of critical utilities experts with a combined experience of more than 500 years. Much of the team responsible for the earlier versions of the Water and Steam Systems Baseline Guide returned to contribute to the revised Guide, providing continuity and Gevity of vision to the Guide’s contents.
Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd Edition
Heating, Ventilation, and Air Conditioning (HVAC) systems can critically affect the ability of a pharmaceutical facility to meet its objective of providing a safe and effective product to the patient. The design of these systems requires a blend of Good Manufacturing Practice (GMP) and Good Engineering Practice (GEP) to help provide a safe and healthy workplace, protect the environment, and manage energy responsibly.
The need to update this Guide has become increasingly evident since its original publication in 2009 as options available to HVAC designers and engineers have evolved due to technological advancements and shifting project pressures. The updates reflect these changes, providing readers with a more current perspective on the challenges and resources involved.
This Guide aims to clarify GMP HVAC issues that are critical to the safety, identity, strength, purity, and quality of pharmaceuticals, biopharmaceuticals, advanced therapy medicinal products, and medical devices, from raw materials to finished products. It covers HVAC control and monitoring requirements and addresses GEP issues related to sustainability, economics, and environmental health and safety. The Guide provides best practices for implementing international regulatory and industry guidance, with appendices containing industry examples and templates for the reader’s reference.
Applicable to HVAC engineers regardless of experience level, this Guide also provides Quality professionals with an understanding of system parameters important to product quality and patient safety. An overview of HVAC-specific building automation controls and environmental monitoring is presented. Business driven specifications are also discussed, such as redundant systems and custom air handlers.
Additional topics include:
Supporting information and HVAC practices for different facility types
Establishing HVAC Design Criteria
Energy Use and Sustainability Considerations
System Configurations by Facility Type
HVAC and Environmental Controls and Monitoring
Commissioning, Qualification, and Quality Risk Management
Lifecycle Documentation, Operations, and Maintenance
The information provided in this Guide reflects the cumulative knowledge and experiences of the authors, editors, and reviewers with input from members of the ISPE HVAC Community of Practice (COP).
Good Practice Guide: Good Engineering Practice 2nd Edition
Running a business efficiently requires working practices that will deliver optimum value for a given scope of work. The adoption of Good Engineering Practice (GEP) can lead to a balance of expenditure and activity in relation to benefits. Benefit is most likely gained when finite resources are focused on identified higher risk aspects or when high risk aspects are more intensely controlled to enable reliable delivery and seamless production. Specific potential benefits include facilitation of speed-to-market of regulated products through efficient delivery of manufacturing facilities and systems and an optimized level of quality oversight, commensurate with the maturity of established GEP.
The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. This Guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP.
Updates for the second edition include alignment with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) which incorporates ASTM E2500, EU GMP Annex 15, ICH Q8, Q9, and Q10, and applicable regulatory guidance. This Good Practice Guide incorporates the concepts and application of Quality Risk Management (QRM), specifically the application of GEP as an enabler for QRM-based integrated Commissioning and Qualification (C&Q).
The structure of the Guide divides GEP activity into the following categories:
Core Concepts
Risk Management
Cost Management
Organization and Control
Innovation and Continual Improvement
Practices
System Lifecycle Processes
Project Engineering Management Practices
System Design Practices
System Delivery Practices
Operational Support Practices
Ancillary Support Practices
Enabler
Engineering Quality Process
This Guide was developed through the collaboration of representative professionals from various sectors and geographic regions of the pharmaceutical industry with the intention of determining a common understanding of the concept and principles of GEP.
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