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ISPE Guidance Documents, with their practical and effective solutions, provide the latest regulatory standards to support the pharmaceutical and biopharmaceutical industry worldwide in manufacturing quality medicines for patients.

Developed by pharmaceutical manufacturing industry professionals, each guidance document is an essential resource for anyone working or overseeing lab work.

Benefits of ISPE:

• The ISPE Guidance Documents have a strong reputation: high quality, practical and credible, as they are written by experts in the field.
• The ISPE Portfolio stands out as it also focuses on best practices in manufacturing, not just product discovery and development.
• The ISPE Portfolio covers a large variety of topics across many industries whereas competitors have a more niche focus.
• Guidelines are accessible to both members and non-members, unlike for competitors such as Parenteral Drug Association (PDA) Technical Reports, which operates an access-for-members-only model.

To date, 95+ individual titles and over 30 topics and 7 language-based packages are published, with more to come in 2024.