Resources · GMP documentation

Everything here names the regulation
it was written from.

Writing on GMP batch documentation for QA teams at small and mid-size manufacturers, by Kinjal Patel — twelve years in pharmaceutical quality assurance. Every piece is written from the regulation it cites, not from a summary of it. Nothing sits behind a form.

Articles

What we are writing.

Everything here is readable in full without an email address. There is no signup form on this page and there will not be one.

Byline

One author. Her name is on all of it.

Every regulatory statement on this site is signed off by her before it goes live.

Kinjal Patel, co-founder and CEO of PharmaSynapse
“I have written the documents these pages describe, and I have defended them in an inspection. That is the only qualification these pages claim.”

Kinjal Patel · Co-founder, PharmaSynapse

  • QMS
  • Validation and qualification
  • Vendor management
  • Quality risk management
  • Documentation
  • IPQC
  • Oral solids and injectables

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If you would rather see the software than read about it.

We are letting a small number of manufacturers in early. You send one approved master formula and your current record format. We draft it, then walk the output line by line — Kinjal on the record, Mitesh on the system.

There is no pilot yet and no deployment data.

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