These resources are just one of the many benefits of being a PPD COP Member.
Join the PPD
COP and ask questions in the community discussions and gain solutions to real-world problems. Also, share
your experience and expertise by responding to inquiries.
Note that only ISPE Members can engage in these activities. If you are not an ISPE Member, join ISPE and take advantage of all the benefits that
membership has to offer.
- EMA Draft Guidance – Guideline on Process Validation (29 March 2012)
The guideline is brought into line with ICH Q8, Q9 and Q10 and replaces previous guideline on process
validation. Continuous process verification (CPV) has been introduced as an alternative to process validation
based on continuous monitoring of manufacturing performance.
- EMA Guideline on Real Time Release testing (formerly Guideline on Parametric Release)
This guideline outlines the requirements for applications that propose RTR testing for active substances,
intermediates and finished products. It also outlines the different requirements that have to be fulfilled in
the application and the need for interaction between quality assessors and GMP inspectors in the approval
Draft Guidance - Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation
This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug
applications (ANDAs) regarding what criteria should be met to facilitate the evaluation and labeling of
tablets that have been scored.
- A-Mab: A Case Study in Bioprocess
Final version of the CMC Biotechnology Working Group’s QbD case study entitled “A-Mab: A Case Study in
Bioprocess Development”. This is the culmination of over a year of work by participants of the BWG
representing Abbott, Amgen, Genentech, GlaxoSmithKline, Eli Lilly, MedImmune, and Pfizer, and work upon which
PQLI will continue to build.
- Pharmaceutical Development Case Study: “ACE Tablets”,
prepared by CMC-IM Working Group (March 2008)
Produced as a Development Report for a small molecule tablet developed using the science- and risk-based
approach using roller compaction. It is intended to help guide FDA and the industry toward the “desired
state” of pharmaceutical quality envisioned for the 21st Century.
- Mock P2 for "Examplain"
Hydrochloride - Draft Discussion Paper
The overall objective of this publication is to facilitate a scientific and regulatory dialogue between the
Industry Association, EFPIA and Regulatory Authorities on the presentation of enhanced product and process
understanding in regulatory dossiers, as suggested by ICH Q8 guideline and how this could provide
opportunities to develop more flexible regulatory approaches.
ISPE has developed concise, summary documents called Knowledge Briefs to help address the industry's need
for current, relevant, and useful content.
GMP Mini Regulation Handbooks
The GMP Institute (GMPI), founded in 1977 to help companies comply with FDA's GMP regulations, was
acquired by ISPE in 2000. These handy pocket-size booklets are an ideal way to keep everyone informed of FDA
regulations and guidelines.