Indispensable in manufacturing and processing operations: Checklists and instructions for use in the testing of packaging material

Packaging defect evaluation lists consist of comprehensive, detailed documents drawn up by noted experts on pharmaceutical and cosmetics packaging testing and are obligatory for efficient and systematic quality assurance.

The lists are oriented to GMP Rules, pharmacopoeias (EP, USP, JP), statutory provisions and directives and technical standards EN ISO 2859‐1 and DIN EN ISO 15378, ANSI Z1.4 (formerly MILSTD 105) and include a classification of defects, sampling tables and detailed descriptions of testing procedures to facilitate practical work.  

Written in cooperation with renowned manufacturers this new edition of the Defect Evaluation List for Rubber Parts has been fundamentally revised according to the current state of knowledge and technology and adapted to the defined quality standard including an illustrated four‐colour appendix with example images of specific defect characteristics.

Indispensable in manufacturing and processing operations:

Checklists and instructions for use in the testing of packaging material Packaging defect evaluation lists consist of comprehensive, detailed documents drawn up by noted experts on pharmaceutical and cosmetics packaging testing and are obligatory for efficient and systematic quality assurance.

The lists are oriented to GMP Rules, pharmacopoeias (EP, USP, JP), statutory provisions and directives and technical standards EN ISO 2859‐1 and DIN EN ISO 15378, ANSI Z1.4 (formerly MILSTD 105) and include a classification of defects, sampling tables and detailed descriptions of testing procedures to facilitate practical work.

Written in cooperation with renowned manufacturers and the Germany-based Joint Association of the Aluminium Industry (GDA) this new edition of the Defect Evaluation List for Tubes Made of Aluminum has been fundamentally revised according to the current state of knowledge and technology.

Indispensable in manufacturing and processing operations:

Checklists and instructions for use in the testing of packaging material Packaging defect evaluation lists consist of comprehensive, detailed documents drawn up by noted experts on pharmaceutical and cosmetics packaging testing and are obligatory for efficient and systematic quality assurance.

The lists are oriented to GMP Rules, pharmacopoeias (EP, USP, JP), statutory provisions and directives and technical standards EN ISO 2859‐1 and DIN EN ISO 15378, ANSI Z1.4 (formerly MILSTD 105) and include a classification of defects, sampling tables and detailed descriptions of testing procedures to facilitate practical work.

Everything you need to know about practical approaches in both pharmacovigilance and obtaining marketing authorisation.

Pharmacovigilance is determined by guidelines, regulations and directives subject to constant change, meaning that keeping abreast with developments is vital. In this book proven experts show you the way to successful pharmacovigilance, step by step.

From the contents:
Side Effects & Reporting · EudraVigilance · Signals and Signal Detection · German Pharmaceutical Industry Association Guideline on Dealing with Signals · Risk Management Plan (RMP) · PSUR & PSUSA · PRAC · Referrals · Risk Communication: Red Hand Letters (RHB), DHPC, EduMat · Maintenance · German Pharmaceutical Industry Association Action Plan · PV Audits · Data Protection: Legal Options Regarding PV Measures · QPPV and Delegation · PV Contracts

This handy manual fills you in on every Detail.

A Crucial Contributor to Pharmaceutical Value Creation and Quality System Performance

From Compliance to Excellence — How does your Laboratory Compare?
Quality control is essential in determining pharmaceutical value creation and overall performance. The OPEX experts focus on this long-neglected topic, based on findings from several years of research at the University of St. Gallen. The authors and editors also present the results of a 3-year project associated with the FDA Quality Metrics Initiative. Numerous case studies from the pharmaceutical industry point to how effective quality control laboratories today rely on continuous optimization.

Get to know the different implementation options within quality control. Practical examples illustrate qualitative and quantitative results and include successful concepts, current industry trends and challenges. All this supports you in the sustainable lean transformation of your laboratory.
Take the path from CAPA to PACA!

Before, during and after production, cleaning and disinfection to the highest standards are a must.

 But how to go about it? Clearly-formulated information and substantiated facts on the subject matter are presented in this book, along with valuable suggestions for problem-solving and hand-on tips for effective and efficient daily work.

Tight deadlines, cost pressure and insufficient time for targeted advanced training are the frequent causes of dwindling application knowledge. Based on the authors’ longstanding experience, this book is the right introduction to cleaning and disinfection in pharmaceutical settings, whether for newcomers to the field or those interested in advanced training and in need of practical, on-the-spot knowledge.

No beating about the bush – just solution-oriented expert knowledge explained in an accessible manner.

The subject areas include hygienic design and GMP, hygiene in processes, plants and immediate surroundings, cleaning technologies and procedures, disinfection, decontamination and microbiological monitoring as well as cleaning validation and its adherence.

Complete with track-tested guidance for successful and sustainable staff training.

Stable or unstable? – What’s the durability of your medicinal products like?

Stability is one of the key critical-to-quality characteristics in the field of medicinal products, making stability testing of vital importance, both in developing pharmaceutical APIs and preparations and obtaining their marketing authorisation. 

The 4th and revised edition (2022) of this specialist publication presents every aspect of stability testing in the area of medicinal products, and includes all ICH guidelines and EU requirements. Ordered according to official requirements and concerning all stages in the development of medicinal products, it exhaustively describes the practical implementation of tests regarding storage, temperature, moisture, light, transport and many other test parameters and includes numerous examples. The reference work is rounded off by assessment of durability in hospital and laboratory pharmacies.

Contents:

• Fundamental principles
• Official requirements and guidelines
• Stability testing and analytical development/preparation of synthetic APIs
• Assessment of durability in hospital and laboratory pharmacies

Essential – indispensable – obligatory: This “classic” will show you the way.

With 15 essential articles from pharmind and TechnoPharm publications since 2019.

The dossier bundles the most important articles from both trade journals pharmind and TechnoPharm since 2019 on the topic of cannabis. This provides you with comprehensive and quotable expert knowledge - without any research effort! The unabridged, unrevised articles describe the development of the topic from different perspectives in chronological order.

• Legal framework: GSAV, register studies, BtMG, SGB, AMG 
• Supply in the SHI market: trends and distribution models
• Digitalisation and blockchain in production and supply chain: quality assurance, traceability, sequencing of plant genomes
• Impurities in analytics
• Mental illnesses

The Cannabis Dossier is exclusively available from the Editio Cantor Verlag.

DOSSIER-Partner: Hoffmann Neopac AG

Real (top) class
For the production of sterile products, the most technically sophisticated solutions are developed, which - in terms of patient safety - belong to the top class. In extreme cases, it is a matter of nothing less than life and death: patients' lives are saved with sterile medicines, and for this purpose every possibility of microbial contamination must be reliably eliminated in the manufacturing process of these products. 

State-of-the-art technology only functions with maximum efficiency if the sound technical knowledge is also up to date. In a joint effort, the authors published this practical book based on many years of expertise and diverse experience, always keeping the new Annex 1 in mind.

From the contents: Contamination Control Strategy - Isolator Technology - Restricted Access Barrier Systems (RABS) - Cleanroom - Aseptic Filling - Terminal Sterilisation Processes - Blow Fill Seal Technology - Testing for Sterility

Validation and qualification are indispensable in the pharmaceutical industry:

In the 4th, revised and expanded edition, the ptj edition GMP-/FDA-gerechte Validierung offers an up-to-date and comprehensive overview here. 

This new edition explains and comments in detail on the changes in the revised Annex 15 - also with regard to FDA aspects; followed by implementation examples of the regulatory requirements. A series of contributions on effective and efficient qualification - from the basic principles to planning, implementation and comparison with the regulations - as well as contributions on the qualification of a packaging line as well as air handling equipment, transport verification vs. transport validation, computer-aided equipment, cloud computing and eValidation complete the relevant areas.

From the contents: 
Regulatory requirements - Risk analysis - Qualification - Process validation - Cleaning validation - Packaging validation - Transport validation - eValidation - Documentation

The pharma technologie Journal is both a practical report and a reference work, thus enabling the efficient implementation of GMP requirements in day-to-day operations. The scientific series of publications deals with specific topics in pharmaceutical technology in the form of individual volumes. The issues are selected by a scientific advisory board and published by Concept Heidelberg.