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Pharma Times - July, 2026 [Free Download]
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APIC GDP for APIs – “How to do” Document | Version 3 – June 2026
A valuable reference for professionals involved in the distribution, storage, transportation, quality systems and regulatory compliance of Active Pharmaceutical Ingredients (APIs).
The latest APIC “GDP for APIs – How to do” Document, Version 3 (June 2026) provides practical interpretation of the EU Good Distribution Practice requirements for APIs, while taking into consideration WHO guidance, ICH Q7 and relevant veterinary API requirements.
🔹 Key areas covered include:
- GDP requirements for API distribution
- Quality Management System & Quality Risk Management
- Personnel responsibilities and training
- Documentation & Data Integrity
- Supplier and service-provider qualification
- Storage and transportation controls
- Deviation, CAPA and change management
- Traceability and supply-chain controls
- Handling of non-conforming materials
- Practical implementation approaches for API distributors
The document is particularly useful for QA, QC, Regulatory Affairs, Supply Chain, Warehouse, Distribution, Compliance and Auditing professionals working with APIs.
APIC emphasizes that the document provides practical explanations and examples for implementing GDP requirements, while alternative approaches may also be acceptable when appropriately justified.
📌 Recommended reading for anyone involved in API GDP compliance and pharmaceutical supply-chain quality.
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ISO 14000: Environmental Management Standards Engineering and Financial Aspects
There is widespread concern about environmental matters in all developed countries around the world, and public interest in this is now so great that the implementation and operation of an efficient and effective environmental management system (EMS) is as important to the financial well-being of a company as it is to the environment that it is intended to protect. Apart from incurring financial penalties when environmental protection legislation is breached, a greater problem that businesses face is that poor environmental performance can lead to a boycott of a company’s products and services by customers, with consequential serious damage to its financial health.
In extreme cases, the general public may also take direct action that hinders or even shuts down a company’s operations.
ISO 14000 is a descriptor for a set of standards that have been developed in response to this global concern about the environment. These standards represent a consensus agreement by national standards bodies around the world about the procedures that need to be followed in establishing an effective EMS. The primary standard amongst this set is ISO 14001, and the fundamental aim of this book is to cover the procedures that should be implemented by a company in order to satisfy the requirements laid down in this standard.
Environmental management to ISO 14001 standards is of similar importance to quality management to ISO 9001 standards in today’s businesses, and the linkage between the two will be stressed in the text. Apart from the need to satisfy the stringent environmental control legislation that exists in most developed countries, the image of a company is damaged if pollution incidents occur, particularly if these are identified by environmental pressure groups, and this can have a severe impact on the marketability of products and services provided by the company. Conversely, ISO 14001 certification can have a very positive impact on a company’s business, in view of the widespread public interest that now exists in environmental protection.
Whilst many texts are available that cover the management considerations in implementing environmental protection procedures that satisfy ISO 14001, these usually give little guidance about the necessary engineering procedures that are involved, or the associated financial implications. This text is intended to fill that gap, and its primary aim is therefore to provide a cross-disciplinary approach that bridges the management field and the engineering field. The book firstly presents the requirements of ISO 14001 environmental management systems, secondly summarizes the company management schemes and procedures required for implementation of ISO 14001 systems, and thirdly discusses the engineering considerations and procedures necessary to ensure the successful operation of ISO 14001 systems. The relevant financial considerations are discussed throughout.
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International Standard ISO 14001 Full PDF
EXPRESS PHARMA DIGITAL ISSUE December 2025
IN THIS ISSUE
COVER STORY
The Next Frontier: India's Rise In Global Healthcare
EDITOR'S NOTE
A biosimilar boost amid trade barriers
INTERVIEWS
CPHI-PMEC SPECIAL
• Overcoming oral delivery challenges: The science behind scalable enteric capsules
• India's next leap: From batch dependency to continuous quality leadership
• India’s pharma packaging: Evolving from cost to care
• E-pharmacies: Fueling India’s digital healthrevolution
• Coding and FDCE: Redefining regulatory compliance in health
• The particle puzzle
• India’s pharma packaging: Evolving from cost to care
• The invisible threat: Why packaging inks are the next major recall risk for pharma
• The constraints and innovations in the packaging of biologic drugs
• Stevanato Group outlines packaging solutions for the expanding biologics market
• SRICO strengthens collaboration with JULABO
• The next-generation of manufacturing: Smarter, faster, greener
• Delivering precision and sterility at scale
Express Pharma Magazine November 2025






