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The right CGMP consultant is one with documented, hands-on experience in your specific dosage form, senior-level quality leadership in real manufacturing environments,…
Read moreFinding the Right CGMP Consultant: What Manufacturers Should Look ForBlog
Steripharm Solutions LLC is a U.S.-based FDA compliance and pharmaceutical quality assurance consulting firm founded by Pramod Sharma, Ph.D. — a senior-level…
Read moreWhy Steripharm Solutions? Meet the Team Behind Practical CGMP ComplianceBlog
Batch record review is a documented quality review used to verify that manufacturing and testing activities were performed according to approved procedures…
Read moreBatch Record Review in Pharma: What QA Should Check Before ReleaseBlog
A pharmaceutical vendor audit is a risk-based assessment of a supplier, CMO, laboratory, or service provider against applicable quality and CGMP expectations…
Read moreHow to Conduct a Pharmaceutical Vendor Audit: FDA and CGMP ExpectationsBlog
A pharmaceutical CAPA process identifies the root cause of a quality problem, implements corrective and preventive actions, verifies effectiveness, and documents closure…
Read moreCAPA in the Pharmaceutical Industry: Process, Root Cause, and Effectiveness ChecksBlog
The difference between QA and QC in pharma comes down to scope: Quality Assurance (QA) provides system-level oversight ensuring the entire process…
Read morePharmaceutical Quality Assurance vs Quality Control: What Is the Difference?Blog
CGMP compliance sits at the center of nearly every conversation about drug quality in the United States. It’s referenced in inspection reports,…
Read moreWhat Is CGMP Compliance? Requirements, Systems, and Inspection ReadinessStart with clarity
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