GMP Consultants Inc.
GMP Consultants have supported many large and small Pharmaceutical companies to reduce their Deviation, Change Control, and CAPA backlogs. We also provide training on Deviation Processes and Human Error Reductions to help reduce the number of deviations initiated.
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FDA has published a revised version of the Guidance on “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production“ on 16 May 2022. GMP Consultants can provide you with a word by word comparison of the 2006 vs 2022 documents. If…
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ICH has published a Draft Guideline on Analytical Procedure Development Q14 on 24 March 2022.
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ICH has published a Draft Revised Guideline on Validation of Analytical Procedures Q2(R2) on 24 March 2022. The document is a complete revision of guideline to include more recent application of analytical procedures and to align content with Q14.
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Health Canada has published a revised version of “Good Manufacturing Practices Guidelines for Active Pharmaceutical Ingredients” (GUI-0104) on 10 February 2022. GMP Consultants can provide you with a word by word comparison of the 2013 vs 2022 documents. If you…
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