PPD COP Resources

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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.

General Documents

  • FDA Contract Manufacturing Arrangements for Drugs: Quality Agreements, draft. May 2013

    The document intended to define the “Who” and “What” of Contract Manufacturing, establish responsibilities and document the arrangements. Illustrative scenarios are described to help understanding the issues behind Owners and Contracted Facilities. The guidelines ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality Systems are specifically mentioned source of information.

  • SUPAC: Manufacturing Equipment Addendum, draft. April 2013

    This draft guidance combines and supersedes the following scale-up and post-approval changes (SUPAC) guidances for industry: (1) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, and (2) SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum.2 It removes the lists of manufacturing equipment that were in both guidances and clarifies the types of processes being referenced. This draft SUPAC addendum should be used in conjunction with the following SUPAC guidances for industry:3 (1) Immediate Release Solid Oral Dosage Forms — Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation, (2) SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, and (3) SUPAC-SS: Nonsterile Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation.

  • EMA Draft Guidance – Guideline on Process Validation (29 March 2012)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 process.
  • FDA 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.

Knowledge Briefs

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.

Indicates content available to ISPE members only.