D/A/CH Affiliate: Containment Manual (English Translation)

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Published: March 2017
Pages: 174
Table of Contents

Table of Contents ( 511 KB)

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This Manual, created by the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate was created outside the normal process for ISPE Guidance Documents and did not go through a rigorous review to ensure alignment with other ISPE Guidance Documents and accuracy of content. However, ISPE believes the content has value to the industry and is, therefore, making the Manual available to its members and customers, translated into English but unchanged from the original German content.

The manufacturing of Active Pharmaceutical Ingredients (APIs) exposes risks for production workers, patients, and the environment. Various containment solutions and other preventative measures are deployed in order to reduce these risks to the required level.

The ISPE D/A/CH Affiliate: Containment Manual (English Translation) describes the essential elements that must be considered in the implementation of containment technologies and spans the entire lifecycle from the planning to the deployment and operation for both, retrofitting an existing facility or designing of a new pharmaceutical manufacturing suite or facility, right through to the decommissioning.

The ISPE D/A/CH Affiliate: Containment Manual covers pharmaceutical installations for the production of:

  • Solids
  • Semi-solids
  • Liquid dosage forms, sterile or non-sterile
  • Active Pharmaceutical Ingredients (APIs)
  • Clinical samples
  • Laboratory buildings

 The ISPE D/A/CH Affiliate: Containment Manual is divided into the following topics:

  • Fundamental Considerations
  • Risk Assessments
  • Containment Lifecycle
  • Process Requirements
  • Technical Systems
  • Industrial Hygiene Validation
  • Cleaning
  • Personnel

The manual details concepts, processes, and technologies within these topics, supported by visual diagrams and illustrations. In addition, the new international guidelines from the EMA, “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, are also covered in the ISPE D/A/CH Affiliate: Containment Manual.

The ISPE D/A/CH Affiliate: Containment Manual was developed through a collaboration of experts from various pharmaceutical industry disciplines and geographic regions working within the ISPE D/A/CH Containment Community of Practice.

 

  • Sourcing strategies
  • Packaging and labeling approaches
  • Storage and distribution recommendations
  • Regulations categorized by region/country
  • Approaches to management of drug accountability, traceability, complaints and recalls with reference to the original sourcing strategy
  • Regulatory differences between NIMPs and comparators