Quality Agreement Review Tool: Responsibilities Flagged on the QA Paper
A quality or technical agreement arrives as a PDF or DOCX. The same file returns flags on release authority, change control and deviations.
A quality agreement or technical agreement arrives as a PDF or DOCX. The body does not show on the pdf who is named for batch release, who may change the process, or who closes a deviation, and the responsibilities annex may name someone else. Checkory is a quality agreement review tool for that paper. Upload it and get that file back with flags on release authority, change control and deviations, plus a short explanation and an England and Wales pointer.
Before you sign, read the clause that names a party for release. A certification clash goes to a solicitor with the marked file. A supply-chain covenant is a different paper, the modern slavery covenant guide published on 16 September 2026.
Quality agreement review tool
The quality or technical agreement in one upload
Confirm the GMP split. A supply draft belongs on the published supply page. A supplier or services file belongs on the published vendor page.
The same file comes back with flags
Flags sit on the clause. Open Analyse a contract.
RACI on the marked file
Release authority
Flag who the file names for batch release. A matrix cell is not the Great Britain certification.
Change control
Flag a change that can proceed without the other quality unit. No notice period in days is stated here.
CAPA and deviations
Flag who closes the deviation, and any release that comes before the investigation is closed.
Audit
Flag the audit permission. Complaints and pricing are not extra rows. For example, a counterparty quality agreement may name the contract site in the sentence that follows.
“The contract site quality unit shall release each batch for sale.”
Release, change control, CAPA and audit on the marked quality agreement.
| Duty on the file | What to read | What you do with the mark |
|---|---|---|
| Release | Paragraph 12(1)(a) is the Great Britain certification. Paragraph 15 keeps evidence for at least five years. A matrix cell does not certify the batch. | Flag the body and a conflicting annex. A certification-transfer sentence goes to a solicitor with the marked file. |
| Change control | 7.2: changes fit the marketing authorisation. 7.12: no unauthorised change that may affect quality. | Flag a change that can proceed without the other quality unit. |
| CAPA | Section 1.7.16 requires the batch investigation to support certification. Section 3 is not a licence to ship on an open deviation. | Flag who owns the deviation, and any release before the investigation closes. |
| Audit | Paragraph 7.17 requires an audit right. Section 2.2(v): know a critical audit outcome before certification. | Flag that sentence. Four rows only. |
Quality or technical agreement
Pros
- ✓GMP duties sit here: who is named for release, who may change the process, and who closes a deviation.
- ✓On a conflict about quality, APIC template section II.4, July 2017, gives this paper precedence on quality matters.
Cons
- ✗APIC section 2.1 says a quality agreement should not carry commercial or liability terms.
- ✗A quality sentence that fights the commercial supply paper goes to a solicitor with the marked file.
Commercial supply paper
Pros
- ✓Price, delivery and liability caps stay on this paper, separate from the quality agreement.
- ✓APIC section II.4 gives the supply agreement precedence on non-quality matters unless that supply agreement says otherwise.
Cons
- ✗Specs, Incoterms, acceptance and warranties are marks on the published supply draft, not rows on this page.
- ✗This comparison does not build a price schedule.
Quality agreement versus commercial supply
The QA paper splits GMP responsibilities
The quality paper names the GMP split. The supply paper carries price and delivery. The typical mistake is to stop because a quality unit, a supply agreement or an extract already looked at the file. A matrix cell does not certify the Great Britain batch.
Pricing and delivery sit on the commercial paper
FDA's November 2016 guidance says a quality agreement should not carry confidentiality, pricing, delivery or liability caps, and should be separate or severable from a supply agreement. The PDF, read 4 October 2026, is the November 2016 guidance. Docket FDA-2013-D-0558. Should means recommended. The Federal Register notice of 23 November 2016 says it does not establish rights. Its scope is commercial manufacturing.
APIC version 2.0, July 2017, section 2.2, says to define which document governs in a conflict, and that quality lines in the supply agreement should not be contradicted. Sentences are from the July 2017 APIC PDF. The publication page says Final version January 2024 and does not print that PDF. Durations in the template are examples, not a rule here.
The supply draft stays on the supply page
Specs, Incoterms, acceptance and warranties stay on the supply page. Which commercial document wins between a master agreement and an order form is the 31 August 2026 article, order of precedence between a master agreement and an order form.
Upload quality agreement
The steps below upload the quality or technical agreement you were sent. A blank you download is a different result.
Upload the quality or technical agreement
Drop the quality or technical agreement
Use the PDF or DOCX you were sent and confirm it is the GMP split.
Read flags on that file
Walk release, change control and the deviation, with the annex open beside the body.
Analyse a contract at the upload path
The path is /document-analysis. Take a certification clash, an annex clash, or a supply-paper clash to a solicitor with the marked file.
A template download is not this upload
An APIC blank is a starting draft. This page reads the file you already hold.
The annex and the body name different parties
The responsibilities annex names a different party from the body for release, change control or deviations. Rx-360, April 2018, says the primary text and the annexes must align. Take that clash to a solicitor with the marked file. A 2016 host of an older Rx-360 text is not a separate rule.
Annex mismatch
The annex and the body must match
In practice the body and the annex name different parties for release, change control or deviations. The guide, read 4 October 2026, is Rx-360 version 2.0, April 2018. It is a drafting guide, not a mandated standard. Its recommended legal review of the final draft is not this first pass.
A template annex is not this review
The annex that matters is the one already on the file. Practical Law returned no public quality-agreement note on 4 October 2026, so none is invented here.
The tool does not replace a solicitor
Send the marked file when release reads as a transfer of certification, the annex fights the body, or a quality sentence fights the supply paper. APIC's recommended legal review of the final draft is not this first pass.
Pharmaceutical quality agreement review tool
This page flags the uploaded QA paper
This heading is still one upload of the quality or technical agreement, with flags on release, change control and deviations. It does not redline a wider pharmaceutical file.
Rx-360 is a drafting guide
Rx-360 version 2.0 is the guide linked above, not a browser upload of your paper. The sentences you challenge are the ones on the pdf you uploaded.
A responsibilities extract is not the marked file
A page that lists roles and GMP points from an upload is a catalog extract. What you hold here is the annotated quality agreement, with an England and Wales pointer beside the clause.
See the marks on the quality agreement
Analyse a contractGMP quality agreement review tool
FDA separates the quality paper from commercial terms
FDA, November 2016, says a quality agreement defines each party's CGMP activities and cannot delegate statutory CGMP. The owner's quality unit keeps final release. That US text adds no notice period.
The Great Britain certification stays with the qualified person
Schedule 7, read 4 October 2026, is Schedule 7. Paragraph 12(1)(a): in Great Britain the qualified person secures that each batch manufactured in Great Britain was manufactured and checked in accordance with the Regulations and the UK marketing authorisation, certificate of registration or traditional herbal registration, or an equivalent authorisation. Paragraph 15(1) and 15(2): documentary evidence that the batch satisfies paragraph 12, kept up to date and available to the licensing authority for at least five years.
Annex 16, 12 October 2015, is EU GMP Annex 16. Section 4.1: release for sale or supply only after qualified-person certification; until then the batch stays on site or under quarantine. Sections 1.7.18 and 1.7.15: technical agreements are in place, and change impact is evaluated, before certification. Section 1.7.16: investigations, including out-of-specification and out-of-trend results, must be far enough along to support certification. Section 3: an unexpected deviation only if specifications are met, the root cause is corrected, and the impact is negligible. Section 2.1 follows Chapter 7 for a third-party audit.
Chapter 7, in operation since 31 January 2013, is EU GMP Chapter 7. The index is EudraLex Volume 4. A written contract sets each party's duties. Paragraph 7.4 leaves control of outsourced activities with the giver. Paragraph 7.15 says who tests and who releases. The chapter does not decide liability to consumers.
MHRA Guidance Note 5 (2023) is the 2023 note. Paragraph 4.1 ties the licence to regulations 37 to 41, including GMP. Paragraph 5.1: the principles and guidelines are mandatory. Paragraph 5.4: contracted-out work needs a written contract.
Change management on the written agreement
ICH Q10, 4 June 2008, is ICH Q10. Section 2.7(b): outsourced responsibilities belong in a written agreement. Section 3.2.3: test the change against the marketing authorisation, including whether a filing change is required. Section 3.2.2 is the CAPA system. Do not paste it in as the parties' clause.
This page marks the GMP split on the uploaded file
Before the next batch is certified, name the release sentence, the change sentence and the deviation sentence. If the annex or the commercial supply paper names someone else, take the marked file to a solicitor.
The manufacturing draft stays on another page
Specs, IP and tooling, MOQ and quality stay on the manufacturing page
That page is written and not published. Specs, IP and tooling, MOQ and the quality line stay there. This page does not link it.
This page marks release authority, change control and deviations
Challenge those three sentences, plus the audit row. Naming the site quality unit does not move Schedule 7.
Toll versus CMO is not this comparison
Feedstock and a conversion fee are that page's comparison. Here the split is quality agreement against commercial supply.
The supply draft stays on the supply page
Specs, Incoterms, acceptance and warranties stay on the supply page
For that draft, use the published supply page. Those four marks stay there.
This comparison only separates the QA paper from commercial supply
A quality sentence on the supply paper, or a price or liability cap on the quality paper, goes to a solicitor with the marked file.
Vendor paper stays on the vendor page
A supplier or services file stays on the vendor page
That file belongs on the published vendor page.
This page is only the quality or technical agreement
If this upload is the GMP split, read the clause on release, on change, and on the deviation.
A supply-chain covenant stays on the blog
The modern slavery covenant guide stays on the blog
The 16 September 2026 how-to is the modern slavery covenant guide. It reviews one covenant.
This page reviews a quality agreement
The table duties are batch release, change control, deviations, CAPA and audit.
A catalog extract is not the marked file
Contracko lists roles and GMP points from the upload
Contracko, read on 4 October 2026, returns an extract of roles and GMP points and a risk score. That catalog is not flags on the file.
This page returns flags on that file
You keep the upload, with release, change control and deviations marked, and a pointer beside the clause.
A review cycle is not this upload
QAG-Manager routes review, approve and renew
QAG-Manager, read on 4 October 2026, reviews and renews agreements for Owners and Contract Facilities, with electronic signatures.
Ideagen runs a shared document workflow
Ideagen Please Review, read on 4 October 2026, is shared review in a quality platform, not flags on one agreement.
This page does not collect e-sign or comments
No approve button here. INGENEUS, in that 4 October 2026 slice, tracks templates and expiry. Upload at Analyse a contract.
A quality system read is not this paper
Aligntra reads SOPs against a standard
Aligntra, read on 4 October 2026, reads procedures against a standard, including ICH Q10 in beta. The auditor keeps the verdict.
iQuality runs documents, validation and CAPA as a platform
iQuality, read on 4 October 2026, is a system of record for documents, validation and CAPA. It is not this file.
This page marks one quality agreement
One quality or technical agreement goes up. Release, change control, deviations and audit come back marked.
A template download is not this upload
An API or APIC blank is a starting draft
The July 2017 APIC PDF is a template and recommends a legal review of the final draft. A blank is not the file a counterparty already sent.
An excipient template is a responsibility table to fill
A blank table is empty until filled. This page maps four duties already on the upload. Template durations are not law.
This page reads the file the user already has
Drop the counterparty PDF or DOCX and compare the annex with the body.
Chat, Word add-on and lifecycle software
A chat answer is not the marked file
A chat reply is another window. The artefact here is the annotated file, with the risk on the clause.
A Word add-on is not this upload
A Word add-on sits in an editor. This page uploads the PDF or DOCX in the browser.
Lifecycle software tracks a portfolio
Lifecycle software tracks many agreements. This page is one file.
This page returns flags on the uploaded QA paper
Start at Analyse a contract and take a high clash to a solicitor with the marked file.
What you can name before the next batch is certified
Name the release, change-control and deviation sentences to challenge before the next batch is certified, and which annex or supply-paper clash goes to a solicitor with the marked file. That pass is not a qualified-person certification and does not rewrite the agreement.
FAQ
What do I get back after uploading a quality or technical agreement?
The PDF or DOCX you uploaded, with flags on release authority, change control and deviations, a short explanation beside each mark, and an England and Wales pointer where a provision may relate. The table on the marked file has four rows: release, change control, CAPA and audit. You do not get a rewritten agreement or a chat transcript.
Which sentences should I challenge before the next batch is certified?
The sentence that names who releases the batch, the sentence that lets a process, method or specification change proceed, and the sentence that leaves a deviation or its corrective action with one party. Schedule 7, paragraph 12(1)(a), keeps Great Britain certification with the qualified person. Annex 16, section 4.1, requires that certification before release for sale or supply. The sections opened here state no notice period in days.
Does a responsibilities-matrix cell certify a Great Britain batch?
No. Paragraph 12(1)(a) of Schedule 7 to the Human Medicines Regulations 2012 makes the qualified person responsible for securing that each batch manufactured in Great Britain has been manufactured and checked in accordance with the Regulations and the UK marketing authorisation, or the other authorisations named in that paragraph. Paragraph 15 requires the documentary evidence, kept available to the licensing authority for at least five years. A cell that names the contract site does not move that duty.
Where do price and delivery belong when a supply agreement also exists?
On the commercial supply paper. FDA's November 2016 guidance, a US source, says a quality agreement should not cover pricing, delivery or limits on liability, and should be separate or severable from the supply agreement. APIC's July 2017 template, section II.4, gives the supply agreement precedence on non-quality matters unless it says otherwise, and the quality agreement precedence on quality matters. A clash goes to a solicitor with the marked file. This page does not build a price schedule.
What if an appendix names a different party from the body?
Flag both sentences. Rx-360 version 2.0, April 2018, says the primary text and any annexes or appendixes should align. Take that clash to a solicitor with the marked file. Annex 16 remains the release pointer in the table. It is not the title of that clash.
Who should see a release sentence that reads as a transfer of certification?
A solicitor, with the marked file. The same handoff fits an annex that contradicts the body, and a quality sentence that contradicts the commercial supply paper. APIC and Rx-360 both recommend a legal review of the final draft. That review is not this first pass, and the marks are not a qualified-person certification.
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