External Audit Process | Detailed Explanation 

Audit are defined as mentioned below:

Customers Audits:

An independent examination of quality system's compliance with recognized, accepted standards and policies by a customer and a third party representing the customer.

Regulatory Audit-National/International Drug Regulatory Authorities:

• An independent examination/inspection of certain parts or all of quality system made to compliance with government or other recognized agency's regulations.
• In-case of planned audits, which can be communicated telephonically or through mail, letter to Head QA either Head-Operation/Senior management, they shall forward the details of the audit to the Head/Designee-QA.
• Head/Designee-QA shall circulate the information of audit to all the concern persons through mail that contains the following detail but not limited:
• Auditor agency
• Name of auditor
• Date of audit
• Duration of audit
• Purpose of audit
• Audit Agenda
• In case of the unplanned audit, on arrival of auditors Head/designee-HR shall inform to Head QA about the arrival and guide the auditor to conference room.
• Head-HR shall be responsible for the hospitality of the auditor which includes   picking, boarding, lodging etc.  as asked by the auditors as per company policy.
• In case of unplanned audit, Head QA may ask purpose of the audit and credential of the auditors for their reference and record purpose.
• Opening meeting shall be conducted and a brief presentation shall be given by the Head QA/Designee or GM Plant /Designee. Opening, meeting shall be attended by Head-QA, QC, Manufacturing, Warehouse and other HOD’s and key personals if required. The entire process of audit shall be recorded and lead by concerned department Head or Head QA.
• Head/Designee-QA shall brief the gowning procedure, safety, use of cell phone and other prohibited articles/items etc. After the presentation as per the audit agenda scheduling to be done.  All the Heads/Designee shall be present in their respective department during audit. Documents shall be presented in systematic manner and shall be given for the questions asked.
• Copy of the   documents   if asked   during   audit   shall   be submitted through Head-QA.
• Confidential documents which are private and   proprietary nature will not be made available however a summary or extract can be made available such as self-inspection reports and CAPA logged for self-inspection report, other audit reports, which have confidentially clause for non-disclosing of information.
• During plant visit only Head/Designee-QA, GM Plant and concern department Head   shall   accompany if required other persons shall   also   join as   felt by Head-QA.
• If any sample is required to be drawn by auditor Head/Designee-QA shall provide necessary information related to applicable procedure and required documentation.
• After completion of the audit all the documents shall be archived in their respective place. Internal discussion shall be done and compliance to the observations shall be presented to auditors and closure of observations.
• Photographs if required to be taken by auditor, but prior authorization/permission from the Head-QA shall be required.
• Closing meeting shall be attended by all functional department Heads and summary report prepared by auditors shall be noted if required. Discussion shall be done with auditors.  All the explanation shall be given   by the respective persons and shall   not be interrupted by others.
• Audit report or any notification issued by the auditor shall   be received by either Head QA or GM Plant on behalf of the company.
• After receiving the   audit report if any   nonconformance or suggestions made, shall be discussed between the all department’s concern personnel and accordingly CAPA shall be planned with target date of completion. A response for the target date with CAPA planned shall be sent to Head-QA for review.
• After the review, Head/Designee QA shall follow-up for the compliance and implementation.
• Auditors feedback shall and based on decision Head/Designee-QA shall close the audit.
• Audit compliance report shall be sent to customer / regulatory agency within 30 working days from the date of receipt of audit wherever is applicable.

Do’s and Don’ts During Audit:

Do’s:

• During the inspection all participating persons from a company should behave open, honest and should clearly communicate in order to maintain trust and confidence.
• Any misunderstanding or uncertainty should be clarified as soon as possible.
• Immediate action on potential deficiencies is often regarded as positive attitude and appreciated by inspectors.
• The availability of persons, documents / records or areas to be inspected should be taken care of as requested and reasonable, in order to avoid any impression for un-cooperative behavior or unwanted hiding of items / things.
• Particular Queries/Questions shall be answered by respected responsible person only to show good attitude and high level of GMP understanding.
• If a person, who   is not responsible for a certain task does   not try to answer (often improperly) but instead points out something like “Please apologize”, this is not my responsibility, therefore it is not me to answer your question, but Mr. / Mrs. “X”. Furthermore, an answer should focus on the question rather than to spread out to items, which were not asked.
• If any person having language problem, then other person shall translate the language on behalf of that person.
• If the auditor asks you for some information, then do not make them ask for it again or do not wait to see if they forget about the request.
• Remove records which have been reviewed by the auditor from the audit room and try to show one record at one time.
• Always be positive, keep calm act confident and   proud not defensive during audit since   the auditor of against us or to point out our mistakes they are just doing their job.

Don’ts:

• In the light of the company is not supposed to do last minute change another        construction unless anyhow required / planned.
• Any   action of suitable to hide   items rather than   improving and / or solving a aryl recommended to be avoided, since this may trigger suspicion and   move   into   an unwanted and unsupported inspection atmosphere.
• unnecessary discussion, argument and personnel discussion/ chat in front of the auditor during inspection period shall be avoided.
• Do not talk loud or speak with the others when the auditor is trying to concentrate, read or review the document.
• Avoid undue traffic in and out of the audit room.