JAMES HARRIS ASSOCIATES INC.

Listed below are a number of articles related to pharmaceutical and biotechnology operations. Also listed are numerous FDA regulations and regulatory guidance documents. In all cases, these documents may be accessed directly by double clicking on the underlined hypertext listing.
Many of these documents are available in Adobe Portable Document Format (PDF). Articles in PDF are identified as such in their description. To read these documents, you much have Adobe Acrobat or Adobe Acrobat Reader. If you do not already have Adove Acrobat Reader available on your computer, it may be downloaded at no cost directly from Adobe. To download Adobe Acrobat Reader, double-click here.
This listing is constantly being upgraded, so check it regularly to keep current with changing regulations and technologies.
To access a document, double-click anywhere in the title for the desired listing.
Current Good Manufacturing Practice for Finished Pharmaceuticals. (This is the current regulation)
Manufacture, Processing or Holding Active Pharmaceutical Ingredients. This Guidance document is listed as a draft document. On a practical basis, however, it is the current GMP regulation for the manufacture and holding of Bulk Pharmaceutical Ingredients. Released 20 September, 1996. (PDF)
Final Rules on the Use of Electronic Signatures. According to FDA, these rules, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology compatible with FDA's responsibility to promote and protect public health. The use of electronic records is voluntary. (PDF)
Proposed Revisions to cGMP Regulations for Finished Dosage Forms. Proposed changes to the cGMP regulations for the purposes of clarification. Published in the Federal Register in May, 1996. Following a comment period, it is assumed that this will become the current GMP regulation. (PDF)
Guideline on General Principles of Process Validation. Published in May of 1987, this document is  extremely out of date, but remains the published standard. The new validation section in the proposed GMPs provides better guidance.
Guidance for Industry: 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. Known as SUPAC-IR, this document provides guidance regarding the types of documentation needed to substantiate any formulation or process change following the clinical trial batches. (PDF)
Guidance for Industry: Manufacturing Equipment Addendum to Guidance for Industry For Scale-up and Post Approval Changes for Immediate Release Solid Oral Dosage Forms. This is the equipment companion to the SUPAC-IR document listed above. (PDF)
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. This is the same as SUPAC-IR except covering solid dosage forms that are formulated for modified release. (PDF)
SUPAC-SS: Nonsterile Semisolid Dosage Forms - Scale-up and Post Approval Changes: Chemistry, Manufacturing and Controls, In-Vitro Dissolution Testing, and In-Vivo Bioequivalence Documentation. One more entry in the SUPAC series - this time for non-sterile semisolids. (PDF)
Computerized Systems Used in Clinical Trials. This is a draft document and does not have official standing. It is still a reflection of FDAs thinking. (PDF)
Submission of Documentation in Drug Applications for Container Closure Systems Used in Packaging of Human Drugs and Biologics. FDA has found that container closure systems play a major role in product stability. This guidance document deals with the information about container closure systems that must be submitted when applying for permission to sell a drug product in the U.S. (PDF)
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. This document is somewhat unique because it is one of the few guidance documents from CBER. (PDF)
Guidance for the Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Vetinary Products. The title of this document tells it all. A must if you are validating sterilization processes or submitting NDAs for sterile products. (PDF)
Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics.
Guidline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Product.
Guidline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances. Similar to the Guideline for Drug Product except that this Guidance Document applies to bulk manufacture. (PDF)