By: Shravan Dubey

Facing Audits/Inspections

Internal Audits / Self Inspections

Customer Audits

Kinds of Audits

Audits

Regulatory Audits

Other audits (ISO, EHS,

CQA, commercial

visits)

Intentions of Audits

To verify the systems /process as committed by the firm, in view of patient safety.

To collect the evidences (that the correct medicine with

assured quality is achieving to patient)

He may be our relative

or we own!!!

Reason for Audits

To verify the:

Assessing compliance status

Approving of new

facilities

Issuing new

permissions

Renewing of license

Periodic visits

Investigations purposeRecalls

Serious complaintsCounterfeits

Due diligence

Business or

technical capabiliti

esPeriodic reviews of complianc

es

Importance of Audits

New business opportunities Business continuity Market leadership advantages Easier and faster regulatory approval System compliances To improve quality management systems To improve the quality of product To meet the cGMP

Facing of AUDIT

Opening Meeting

Do’s Welcome of Auditors

Self introductions Share business Cards

Scope of audit should be discussed Limited general talk with mild smile Notify auditors up fronts

Opening Meeting

Do’s Effective presentation with soft colors Tea or Coffee should be ready Bouquet or flower should be on table

Map the facility describing various area Print out the copy of presentation Keep ready the Organizational chart

Remember!!!First Impression is the last

impression

Opening Meeting

Don'ts Absent during welcome Long talk Absence of subject matter Exceed smile Through business cards Take long time for discussion Whisper

Preparations for Audit

Back room should be strong Subject matter experts should be present All possible documents should be available Runner for fetching of document in time Person as “SCRIBE” to keep notes Extra stationary should be available (transparent folders,

stapler, stapler pins, office files, etc…. Washroom facility should be in executive conditions Lunch should with suitable food

Preparations for Audit

All Quality Documents should be reviewed Product related informations should be

available APQR from last three years (minimum) Process flow diagram Vendor details and documents RM details (using in manufacturing) Hazardous material handling informations Information about Product manufacturing

at site Facility housekeeping along with

surroundings Safety practices Safety slogans Emergency numbers, ambulance

availability Preventive maintenance documents

Paste control documents Recruitment policy Attendance system policy Outside training details Workmen training details Dressings of employees should be clean Personnel hygiene awareness

Back room

Review of documents quickly before of it goes in to hands of Auditor.

Give and take record Qualification records All department SOPs Site master file, VMP, Quality Manual Stability data Particular product validation (process and cleaning), BMR,

Specifications Site lay out Experts for subjects

Facility Tour

Facility housekeeping should be excellent Outlook should be perfect (Painting, Lightening and

scheduling) All shop floor personnel should be confident for their work Be clear and be transparent with respect to our work Knowledge of subject which is being done Flawless tour from Material entry to Material exit If found any deficiency : first convince the auditor if it is

actually not which auditor under stood. If it is deficiency then accept it and commit to resolve.

Documentation

Do’s Should be given within 5 minutes Should be in presentable condition. Serve the document on desk to desk Remove documents if it is review (with permission) Reply only those questions which are asked Be clear during Q&A with inspector / auditor Speak with confidence Answer with facts along with evidences Every thing which is said to auditors should be on record

Documentation

Don’ts No mixing of documents No additional reply or over answer Don’t use work “I think” Don’t argue during discussion (by third person) Use word “excuse me” if any addition Don’t afraid of silence Don’t leave alone the inspector / auditor Don’t laugh more than enough

During the Audit

Unacceptable points: Become defensive and start arguments Make blunt refusals on the requests Speculate or guess an answer Respond to questions outside your expertise Attempt to answer a hypothetical question Intentionally mislead of lie Start blaming others or departments for the mistakes Make any personal comment on the quality of the investigator Generate questions by offering un-requested information or asking questions

of the Investigator Recording investigator discussions in the audit room

Your behavior

Should be Polite Good listener Good Acceptor Positive attitude Technically sound Well experienced subject

matter Gentle Well dressed Good convincer Supportive

Should not be use “I” Think Suppose Believe Usually Sometimes By practices To be honest

Wrap up

Take a diary for notes (general observations) Thanks speech for auditing the facility Share the learning's Keep eye contacts Ask “is there any critical issue”. Arrange to provide documents (is asked by auditor during audit) Gifts hand over session if required Leave them up to their Cars Say “bye and take care”

Response

Say thanks after receiving of observation report Provide time line for the completion of compliance report Share the compliance report along with evidences Follow up for the receipt of the compliance report Follow up for the closing of observations

Thank You