Two sites agreed a process change by email. One ran the old parameters.

• Agreed by email. Not in the receiving site’s batch record.

  After two lots over-granulate, development and the sending site agree to end granulation by torque, not time. The receiving site’s batch record draft still says fixed time.

  A failed engineering batch, and weeks added to the transfer.

  Process changesGranulation, site B transfer

  TorqueEnd point by torque, not fixed timeEmail, development and site A quality, 6 Nov

  • Site A batch record v5TorqueUp to date
  • Site B batch record v4Fixed timeNot the latest
  • CDMO protocolTorqueUp to date

  Asked site B to revise step 6 before engineering batch 1, and flagged it for change control.

  Records the decision with its evidence, checks each site’s documents against it, and raises it for your change control.

  Your team decides: Approval, through change control.

• A supplier’s change, mentioned in a cover email.

  An API supplier moves a recrystallisation step to a new building and changes a solvent grade. It tells the sponsor’s procurement contact, and supplier quality and regulatory never see it.

  Lots on hold, requalification, and possibly a filing to amend.

  Supplier changesAPI-221, intermediate

  FYI, from Q1 the recrystallisation moves to our Block C, with a higher-grade solvent. No impact expected.

  Change

  New building, new solvent grade

  Affects

  API-221, used in three products

  Change control

  Not raised

  Sent it to supplier quality and regulatory, and asked the supplier for a formal change notice.

  Reads supplier emails and certificates for a new site, grade, method or limit, and asks QA to log it.

  Your team decides: Whether it needs change control or a filing.

• The limit was tightened. The lab tested to the old one.

  After new stability data, the sponsor tightens an impurity limit and emails the CDMO and the contract lab. The lab keeps reporting against the old limit, and its certificates still say pass.

  Retesting and a release delay, if it’s caught at review.

  SpecificationsLot 2291, certificate of analysis

  Item	Current spec	Lab’s certificate	Check
  Impurity B	0.10% max	0.13%, “pass”	Out of spec
  Assay	98.0 to 102.0%	99.4%	Matches
  Water	0.5% max	0.3%	Matches

  Told QA and QC, and sent the lab specification version 7.

  Reads each certificate against the current specification, not the one the lab has, and tells QA and QC before release.

  Your team decides: Disposition, by your quality unit.

• The lab knew on Friday. The sponsor heard the next Thursday.

  A contract lab confirms an out-of-spec stability result on a distributed batch, and emails its CDMO contact. The CDMO tells the sponsor’s QA six days later.

  A late field alert, and a likely inspection finding.

  In the US, a field alert is due within three working days, and the clock can start the day a contract lab finds the problem.21 CFR 314.81; FDA field alert Q&A, 2021

  DeviationsLot 2264, 12-month stability

  Out of specification, on a distributed lot

  1. Contract lab, Fri 16:10Result confirmed, emailed to the CDMO.
  2. CDMO quality, Mon“Investigating, will update.”
  3. Sponsor QANot told yet.

  Field alert dueWed, close of business

  Sent the lab’s email to sponsor QA and the field alert owner on Monday.

  Starts the clock from the first message about the result, not the day someone logs it, and alerts QA and whoever files the alert.

  Your team decides: Whether it’s reportable, and the filing.

• The plant changed. The filing didn’t.

  A CDMO adds a second filter supplier, and the development lead agrees by email. Regulatory hears three months later, after batches were made with it.

  Batches that may not ship until the change is filed.

  In the US, a moderate change needs a supplement at least 30 days before product made with it is distributed.21 CFR 314.70(c)

  Regulatory filingsProduct 3, sterile filtration

  Item	CDMO email	Change control	Filing tracker
  Second filter supplier	Agreed, 12 Jun	Not raised (doesn’t match)	Not assessed (doesn’t match)
  Hold time to 14 h	Agreed, 3 Jul	CC-0418	No filing needed

  Asked QA to raise change control, and sent the email to regulatory.

  Links every change it reads to the products it touches, and flags one with no regulatory assessment.

  Your team decides: How the change is classified and filed.

• A report promised for the 15th, and nobody chased it.

  After an audit, the CDMO promises a revised investigation report by the 15th, in an email. Nobody follows up, and a batch waits for certification.

  Release held for days or weeks, and the same finding at the next audit.

  CommitmentsOpen commitments, CDMO site 2

  • Revised investigation, DEV-0412CDMO quality18 daysOverdue
  • Stability protocol sign-offCDMO QC4 daysDue Fri
  • Hold-time dataSponsor development2 daysReceived

  Draft to Meera, CDMO quality

  Hi Meera, the revised investigation for DEV-0412 was due on the 15th. Lot 2302 is waiting on it for certification. Can you share it by Wednesday?

  Approve and send

  Takes commitments from emails, chats and minutes, watches for the delivery, and drafts the follow-up when one goes quiet.

  Your team decides: How the partner is rated.

Sample data. Names, documents and figures in the examples are illustrative.