The purpose of this SOP is to lay down the procedure for handling of external inspections / audits by the agencies and customers for various products.


This procedure is applicable for handling of external inspections / audits.


Site Head:

To welcome auditors at opening meeting.

To follow the procedure as per SOP.

Head QA:

To co-ordinate with concern department Head regarding auditors requirements.

To facilitate audit in respective departments.

To follow the procedure as per SOP.

Department Head:

To participate in audit.

To follow the procedure as per SOP.


Head QA shall be accountable for the compliances of this SOP.


External audits may be from any of the following agencies but not limited to:

World Health Organization.

Any other regulatory or government body domestic or overseas.

External customers (Indian / Overseas).

Site Head / Head Quality Assurance shall be the principal co-coordinators at the site. Wherever necessary, Head of QA can be at site during the audit.

For any scheduled audit, on receiving the information about audit, the principal coordinator notifies the same to head of concerned departments / sections for their availability at site on the scheduled dates.

Feeble movement and not more than four person can visit the functional departments same time.

For any unscheduled audit i.e. if the audit agency do not inform about their arrival at site in advance and comes to site on a weekly off or at any given moment of time in any shift, then following procedure shall be followed:

The security person / in-charge welcome them and make necessary arrangement for their sitting on security gate or reception. Identity / visiting card shall be verified by security person. Appropriate document formalities shall be done as per the relevant procedure.

Security in-charge shall be inform about the arrival of auditors to site Head, QA Head, QC Head and other concerned person on mobile or intercom.

If the auditors request to visit workplace, any responsible person available at the site shall escort the auditors to the workplace till the arrival of site Head, QA Head, QC Head and other concerned person on site.

If the area is not operational at time, then they are requested to visit the area once concerned plant people are available at site. The waiting period is shortened as practically as possible. However if auditor insist then security-in-charge shall facilitate the auditors.

During such type of audits primary focus of auditor or auditee is on the audit and other formalities like opening meeting etc. can be considered later.

Head of Human resource shall be notified to organize necessary hospitality arrangement like, local transport, hotel reservation, ticketing, if required etc.

At the beginning of the audit, the principal coordinator makes a brief presentation of the company’s business activities in general and an overview of manufacturing activities at site in specific for the benefit of audit team and introduces key operating persons to the audit team.

The principal coordinator (s) shall be present throughout the audit along with the audit team and records all observations during the tour of the facilities as well as during the documentation review.

The principal coordinator draws key members from different operating areas (Warehouse, Manufacturing, Quality Control, Quality Assurance, Engineering and Human Resources) to form a team which represents the organization throughout the audit.

It is the responsibility of the principal coordinator to ensure presence of key members at different operating areas and plays the role of facilitator throughout the audit.

The principle coordinator ensure a wrap up / closer meeting at the end of the audit in the presence of the concerned team and / or the site head and subsequently prepares an action plan for compliance of the different areas with time lines.

On receipt of audit report, principal coordinator shall also ensure formal submission of the responses to audit observations (if any) to the concerned audit agency within the stipulated time period.

The audit response report shall be prepared as per the QMS Tools such as: Risk Assessment, Change Control, Deviation, CAPA and Incident etc.


Audit Compliance Report – Annexure-1

Audit Response Log Book – Annexure-2




About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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