tips for preparing for audit

Ambrose Consulting LtdDeveloping Quality Mindset

Tips on Preparing for a GMP Audit

Linda Ambrose&

Peerayoot Pimhataivoot


Inspection Preparation

RULE NUMBER 1

Inspection preparation is a team effort!

It is (often) led by Quality...but it is not just for Quality to do


Your inspection aims - outcome

No critical issues

Approval of the site/application

Limited observations (ideally none but we dont live in an ideal world!)

No surprises!


Ensure all supporting systems & data are in place

Preparing for a GMP Audit overview of preparation

Anticipate inspection issues take corrective actions if possible prepare position papers if necessary

Prepare personnel to face inspectors team & 1-1 training

Agree & rehearse inspection logistics ensure clear role definition


Preparing for a GMP Audit

Establish SOP for handling Regulatory AuditsHave SOP available well before anticipated audit

Include company strategy to manage the auditFrom opening meeting to audit close out

Include company policy on audit behaviour by staffHonestycooperation


Establish an SOP for handling Regulatory Audits Identify roles & responsibilities (including back-ups)

Receptionist Escort/Co-ordinator Scribe Subject experts Staff likely to speak with auditors

Include companys policy on: Photographs Electronic data Entering controlled areas Sampling



Before the Audit

Establish when audit is likely Initial audit: ask regulatory authorityRe-audit: anticipate when

Determine scope of auditAsk for audit plan Ensure appropriate staff are on-site



Before the Audit

Do your research Previous audit reports (own files; other

companies)

Intelligence on the auditors (areas of expertise & focus; network to find out from others); request their CVs.

Web site information (GMP Guides & Guidelines; Q & As, audit procedures, policies, complaints procedure, appeal rights, etc)



Before the Audit Prepare or update Site Master File and forward to regulatory

authority.

Undertake comprehensive internal audit against the GMP Guide Initial audit: use of GMP consultant can be useful

Review documentation Know location of relevant documentation for easy retrieval Ensure that all circulated documents are controlled copies Review current documented procedures against actual

methods used.



Before the Audit Review customer complaints and any recalls in last 2

years Be prepared to show root cause analysis and corrective actions.

Brief and train staff rehearse!!! Answer questions directly & concisely Do not volunteer information If unsure of answer, do not guess



Before the Audit

Prepare Lists [Not to be shown to Inspector!] (next slide) Review & prepare position statements Train staff & Assign Roles & Responsibilities



Key data summaries needed List of all batches made

one list for each FDA product batch listing for each production

line making inspected product List of OOS

one list for each inspected product one list with all products

List of media fills & results* by filling line with comments on

positives Environmental /utility trend summaries

by area with comments on issues

(*sterile products)

Sterility test positives* list with summary details

Stability testing results for each product

Complaints list for each product

Anomalies & deviations list for each product

Change control list for each product/utility

Rejects Recalls

All data for last since previous inspection


Laboratory - ReviewSub-team to review

SOPs analytical results & trends (including recording

systems) OOS for last 2 years laboratory equipment qualification (IQ & OQ) method validation & transfer personnel training (laboratories) stability testing retained samples

Scope Products concerned first then

all OOS stability


Production - ReviewSub-team to review

SOPs Batch Records Maintenance & Calibrations Production equipment qualification (IQ & OQ) Process validations Personnel training (production & engineering) Change Controls Material and people flows Clearly defined storage areas & conditions


Facilities & Equipment - ReviewSub-team to review

SOPs qualification (IQ & OQ) maintenance (preventative & break-down) calibration

Scope facility & equipment utilised water (purified and WFI) HVAC (temperature, humidity, pressure) other utilities as appropriate (nitrogen etc)


Before the Audit Prepare the site! Ensure Site is Clean & Tidy

Outside Inside remember toilets! Empty rubbish Do repairs

Clear out drawers & desks in production areas Remove everything that shouldnt be there Remove unofficial notices etc



Opening MeetingOn arrival, check identification of the auditor(s)On arrival, ensure they register in visitors book &

are given name badgesReconfirm scope of auditRequest audit plan (to have key staff available)Have available a room where audit team can be

locatedHave your own back room If not offered, request summary session at end of

each day



Before the Audit Prepare for Opening MeetingPrepare Inspectors Information PackSite layout planCompany informationOrganisation chartContact information eg Co-ordinator etcRestrictions/emergency drill etc

Information requested by Inspectors prior to visit



Opening MeetingAdvise auditors/inspectors

IntroductionsCompany safety rulesNo photographsAn escort will be provided at all times while on the company

propertyIf a question cannot be answered by the escort, the responsible

person in the company will be found to provide the answerNormal operating hours are (eg. 8am to 5pm)Set the times for breaks, at lunch, coffee, end of day

Keep companys opening summary succinct 5 mins!!!



During the Audit Mark photocopies given to auditors as uncontrolled copy,

commercial-in-confidence & copyright of X Keep copy of everything given to auditors

Make sure current version is given Attempt to correct deficiencies immediately

Provide evidence while auditors still on site This may impress the audit team

Request that such corrective actions be acknowledged in the final audit report

Prepare internal summary of audit each day Key players meet to discuss if any action is necessary



During the AuditDo not volunteer informationDo not guess the answer; tell them you will find

the person responsible If auditor is looking around without asking

questions, do not ask if you can helpDo not try and hide informationDo not argue or display anger, even if you are

frustratedNever cause deliberate delayAlways deliver (if you have promised something)

Preparing for GMP Audit


Closing Meeting Scribe should attend to compare deficiencies presented

with what he/she recorded Question deficiencies that you do not understand; seek

clarification If a deficiency is clearly wrong, suggest auditor re-visit

the area or document. Discuss any deficiencies that are clearly outside the

scope of the GMP Guide Be cooperative & commit to provide a written response

with objective evidence of corrective actions within an agreed time frame.

Do not be argumentative



After the Audit One person to coordinate corrective actions and

written response to regulatory authority Use internal CAPA system to correct and close out

each deficiency Conduct post-mortem on areas of weakness, &

correct (particularly through staff training) Weaknesses identified by regulatory authority Weaknesses identified by escort & scribe not detected by

regulatory authority



And FinallyAnd Finally

Thank YouThank You

Any Questions?Any Questions?

Tips on Preparing for a GMP AuditInspection PreparationYour inspection aims - outcomePreparing for a GMP Audit overview of preparationPreparing for a GMP AuditPreparing for a GMP AuditPreparing for a GMP AuditKey data summaries neededLaboratory - ReviewProduction - ReviewFacilities & Equipment - ReviewAnd Finally

tips for preparing for audit

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