Tuesday , September 26 2023

Internal Audit and Self Inspection

Internal Audit and Self Inspection

Internal Audit:

An onsite verification of activity used to determine effective implementation of documented quality systems.

Self-Inspection :

Verification of departmental activity used to determine effective implementation of documented quality systems.


To lay down a procedure for periodic internal audit and self inspection, to ensure current Good Manufacturing Practices compliance.


This Standard Operating Procedure is applicable to all departments of all formulation.


Audit Team : Auditing the facility and to prepare audit report comprising of recommendations and corrective action necessary for respective.

Auditee Head : Head of the audited department, to ensure access is provided to internal audit team to the department and relevant documents required by internal audit team. He or she shall also ensure that              corrective actions are taken within a specified time frame as mentioned in the internal audit report.

Head-QA : Audit team constitution, audit schedule approval and distribution of Audit Report. Head-QA shall also ensure the compliance to the

Abbreviations and Definitions

Audit  : Word represents both Internal Audit and Self Inspection.

Auditor : A person who has the technical qualification or is trained or the experience to perform audits.

Auditee  : A department to be audited.


Audit shall be carried out at two levels. Self inspection and Internal Audit

Self Inspection is done at departmental level i.e. representative of department shall perform inspection of all the documents and activities done by the department. Self Inspection shall be conducted once in every two months. The Self Inspection shall have ±7 day’s acceptable tolerance and inspection shall be done within this period. These representatives shall be nominated as auditors by the Department Head and shall have direct reporting to department head. An audit report shall be prepared and corrective and preventive action shall be determined, filed and

Periodic Internal Audit shall be carried out by an Executive(s) of QA & / or by an audit team constituted by head QA in all operational departments. While selecting a team member for audit team the head QA shall ensure that the member is not from the same department for which audit is to be carried out (Refer Annexure-1).

Internal Audit shall be carried out as per the schedule prepared by QA department (For frequencies of Internal Audit refer Annexure-4). The month and department to be audited shall be mentioned in the internal audit planner (Annexure-3), which shall be prepared for a calendar year. This Internal audit planner shall be circulated to concerned department by Head-QA, preferably in the month of January of every calendar year. The actual dates of audit shall be proposed by QA before executing the audit.

Quality Assurance shall mark the upper half box in red colour for planned date and the auditee department shall mark the lower half box in green colour against the planned date as per their suitability.

The internal audit planner shall be distributed in triplicates, one copy each for planned date from QA and the agreed date from the user department and one for QA department for execution reference.

The Internal audit shall have ±7 days acceptable tolerance and Audit shall be done within this period.

If internal audit of any particular department / activity is required towards the investigation/ addressing of the product complaint or product recall the same shall be performed any time.

Internal audit may also be conducted before the inspection of any regulatory body.

During the audit, auditors shall use the checklists for each department as given in Annexure-1A to Annexure-1H, but the scope of audit may not be restricted to the checklist only. In checklist under the ‘Remarks’ column, the auditor shall mention whether the observation is adequate or inadequate.

The audit team shall evaluate systems, processes, and functions of the department to ascertain current level of the cGMP. The audit team shall check for the compliance for the various procedures, raw data and record the findings in “Internal Audit/Self Inspection Report” (Annexure-3).

The Auditor shall assign a seven character number as ‘AAXX/YY’ in consultation with QA to Audit report where;

AA : Denotes the type of Audit i.e.

For Internal Audit ‘AA’ shall be represented as (IA)

For Self Inspection ‘AA’ shall be represented as (SI)

XX :    Denotes respective serial number of Audit.

YY :    Denotes respective year of the Audit.

e.g. Second Internal Audit of the year 2023 shall be numbered as IA02/23 and third self inspection audit in the month of March in the year 20023 shall be represented as SI03/23.

A new series of Audit report No. shall commence at the beginning of every calendar year.

Observation made during the audit shall be discussed with the concerned in-charge of

the concerned department and / or the head of the department. Depending on the nature   of the findings and the risk associated with any non-compliance, the following classifications shall be used:

Critical: – Deficiencies which have a high probability of causing adverse consequences to the patient or consumer or may result in significant deviations in the safety, identity, strength or purity of the product; or are a combination of major deficiencies which indicates a critical system failure.

Major: – Deficiency which could potentially cause adverse consequences to the patient or consumer if left un-addressed could be considered indicative of poor control or are a combination of minor deficiencies which indicate a major system failure.

Minor: – A deficiency which cannot be classified as critical or major. It also includes a deficiency which is not related to GMP or regulatory conformance requirement(e.g.EHS ), but warrant attention by the auditee.

Good Practice: – Demonstration of exemplary achievement of compliance or setting a precedent within the current industry standard.

Upon completion of the audit, audit team shall compile the audit report comprising of recommendations, which shall be forwarded to respective department head for corrective  action and tentative date for compliance. For Internal audit this audit report shall be send through Head-QA.

A register shall be maintained for self inspection by the department auditors and for  Internal audit by QA regarding issuance of audit report to concerned department Head   (refer Annexure-5)

For Internal audit reports concerned department head shall mention corrective action plan and tentative date for compliance based upon audit observations and shall send back  the Audit Report within 15 working days of receipt of internal Audit report to QA.

Upon receiving back the internal audit report, Head-QA or his /her designee shall review  internal-audit report and shall verify the corrective action taken. If required, a follow-up audit shall be carried out by any member of audit team. A review status of corrective action taken shall be mentioned in the respective column of Internal Audit Report. A copy of report compiled by the audit team shall be forwarded to concerned department for final action and compliance.

If required, Head- QA shall discuss the action plans with the respective department head.

If Internal Audit Report compliance is not received by QA within specified time limit of 15 working days, a reminder(s) shall be sent to concerned department head. A copy of this reminder(s) shall be attached with Internal Audit Report.

Finally Head -QA shall notify Head Quality& Compliance about the critical audit findings & corrective action proposed / taken by the Auditee.

Results of previous internal audits shall be reviewed again during the next Internal Audit where no corrective action was taken.

Audit Planning and audit execution process are delineated in the “Flow chart for Internal Audit” for guidance (Annexure-6).

Note:The contents of the audit reports generated following this SOP are confidential and revelations of the observations in the audit reports to external auditors shall be at the discretion of Head Quality Assurance.

Forms and Records

Annexure-1 – Internal Audit Checklist

Annexure-2 – Internal Audit Report

Annexure-3 – Internal Audit Planner

Annexure-4 -Frequency of Internal Audits

Annexure-5 -Internal Audit Register

Annexure-6 -Flow Chart for Internal Audit


Master Copy: Documentation Cell (Quality Assurance)

Controlled Copies: Administration and Housekeeping, Central Warehouse, Documentation Cell (R&D), Engineering, Human Resource and Development, Production, Quality Assurance, Quality Control and Stores



Revision Number

Reason for Revision
00 New SOP
Internal Audit Checklist For Storage of Starting Materials and Finished Products (Stores)


Are incoming material and components quarantine until approved for use
Are all materials stored off the floor
Are materials spaced to allow for cleaning and labeling
1.   Observe the staging area:

i) Is the access to area restricted to authorized personnel

ii) Is there proper segregation of material issued for different batches

iii)  Is there a document indicating material movement in the staging area

Is there a separate area for work in progress goods, If yes

I)     Is the access restricted to authorized personnel

ii)Is the environment conditions monitored and recorded

iii)Are the product distinctly separated and stored

iv)Is there an inventory movement record

Is there a stock rotation program if yes, is it followed. Crosscheck five random readings
Does the finished goods stock adequately maintained i.e. C-boxes closed, taped and status labeled
Is the area segregated for raw and packing material
Is the area adequate for physical separation between different materials to prevent mix-ups
Are the material containers visually inspected, cleaned and weighed at the time of receipt check the receipt log
Is material stored as per their status : quarantine, approved / released or rejected
Are the quarantine, approved / released or rejected area completely demarcated
Are material requiring special storage conditions stored as per requirement
Are the labels with complete information and duly signed by QC and written clear and legible text
Is sampling done as a per the sampling plan by QC chemist
Are the sampled containers labeled as ‘SAMPLED’
Are the containers re-sealed after sampling under supervision
Is sampling being documented in equipment / area log
Is dispensing being carried out in segregated environment
Does the dispensing area have adequate exhaust and environmental monitoring (RH and temperature). Check records
Are the dispensing tools (scoops, spatula, vessels, cylinders) used after wash water analysis / QC certification for release
Is the dispensing area clean and clear of previous dispensing (check the equipment log, if any)
Check for master weights calibration certificate
Observer dispensing operation:

i) Is it conduced by authorized person under supervision of production / IPQC

ii) All dispensed material properly packed in suitable container / double polybag and labeled

iii) All the calculations / weights checked by production / IPQC

iv) Are the original container re-sealed or closed after use

v)   Observe the area after completion of dispensing

vi)   Is there a documented procedure of cleaning of dispensing area after dispensing (i) between batches of same product (ii) between batches of different products

Is the movement of man & material movement logical within stores and from stores to the production area
Is the dispensed material moves under supervision from stores to production
Observe the printed packaging material area :

i)   Is the entry restricted to authorized people only

ii) Is stacking / storage of material adequate

iii) Are the materials of different product and pack size segregated properly

iv) Is the labeling adequate

v) Is there a stock rotation program. If yes, is it properly implemented

vi) Is there a SOP for dispensing printed packaging material

Is there a SOP for return of excess material e.g. line rejects etc from the production to stores
Is there a provision for dispensing of extra or additional material is it followed
Check if the list of employees is available and updated.
Are lighting and ventilation adequate to facilitate comfortable working?
Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
Check if the emergency exits in the building are maintained and unobstructed.
Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?


Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
Check if cleaning records are maintained.
What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
Are the workforce trained in personnel Hygiene is the training documented?
SOP and training of personnel available is the relevant information like study material, attendance record, evaluation record, re-training record etc available.
Are batch distribution records available?

i) Take 2 different batches and trace back their distribution.

Is the current list of distributors available?
Is the list for storage condition of products available?

i) Are products stored as per the storage conditions?

Are there any gaps in Shutter?
Check if fire extinguishers are installed, checked, properly labeled and preventive maintenance records maintained.
Are a complete index and a complete set of SOPs available?
Are the returned goods, recalled goods, expired goods completely demarcated?
Are material requiring special storage conditions stored as per requirement?
Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
Is environmental condition records being maintained regularly and recorded?
Are the weighing balances calibrated, Check records?
Are sewage, trash, etc. disposal system adequate?
Are Proper log maintained& available of all Rejected material in Rejected area room?
Are there any insects (Flies, mosquito’s, etc.) in the buffer zone?
Do the change rooms are neat & maintained properly?
Do Dedusting tunnel working properly?
Are All PVC/PVdC properly labeled and shrink wrapped?
Do All foils are properly labeled and Shrink wrapped?
Do Printed Packaging material Jali are locked?
Do Rail of RM/PM rack movement is Cleaned or not?
Do Foil room is Locked or not?
Do the list of Storage Materials is Displayed on all Storage areas?
Do the Dispensing Booths are properly cleaned and Labeled?
Do Batch Staging Area have a yellow Line?
Do the Door of Dispensing booth and Batch Staging Area locked? Do Container kept in batch staging area properly Labeled?
Are All weight boxes trolley properly cleaned?
Do Calibration records are Available for Above Weight Boxes?
Do all Weights are Shrink Wrapped?
Do All Vacuum cleaners are properly cleaned and placed at respective Places?
Do Label room is Locked or not?
Is there Traceability for every label lock, label quantity in the label room?
Do Humidity & Temperature conditions are maintained in EHG caps area?.
Are there any Dust found in Waste bins ?
Documentation / Quality Assurance
Are process deviations recorded

i) Is the disposition of deviation being done by department head of QA

ii) Are corrective actions taken and recorded

Does the current lists of all the SOPs available

i) Verify the master copies of SOPs

ii) Verify the SOP distribution and retrieval record

iii) Are superseded / obsolete SOPs marked accordingly and preserved separately. Choose any 3 current SOPs and / verify the status of their obsolete SOPs

Are the changes in the process, documents introduces as per controlled procedure

i) Is the record for change control maintained

ii) Is the disposition of change control done by department head of QA

Is the current list of approved vendors available

i) Is the list of vendors segregated material wise

ii) Are the vendors approved by QA verify the records

Is the list of RM / PM available

i)    Verify the code numbers

Is the current list of consultants available
Are market complaints processed and recorded by QA

i)     Verify from the records

ii)    Check the action taken on any 3 complaints

Is the Quality Policy available and displayed
Is the current Quality manual available
Is the current SMF available

i)   Verify that all the information provided in SMF is updated

Are the current plant layouts available

i)     Layouts of level I, II, III, IV

ii)    Layout of ducts

iii)   Pipe route layout plan

iv)   Chilled water piping layout

         v)     LPG pipe lines

Is the organogram of the company available

i)    Does the organization chart demarcates the key responsibilities

ii)   Are all the functional areas headed by key persons with adequate qualification, experience and training

Is the list of key persons available
Is the list of current technical persons available for QC, Production, QA, R&D, Stores and Warehouse
Are current job descriptions available for all the key and technical persons
Are the copies of current manufacturing licenses available
Is the list of all the products available

i) Verify the code numbers

ii) List of products for pharma market

iii) List of products for export market

Does the current lists of specification / STPs for raw materials, finished products available

i)      Verify the master copies of specification / STPs

ii) Verify specification / STP distribution and retrieval record

iii) Are superseded / obsolete specifications / STPs marked accordingly and preserved separately. Choose any 3 specification / STPs and verify the status of obsolete specifications / STPs

Are Master formulae record available for all the products

i) Check the list of current MFRs

ii) Choose any 2 products and verify the Master formula records

iii) Are the master formula records authorized

iv) Does MFR includes expected final yields and intermediate yields

Are batch manufacturing records (BMRs) issued and controlled as per the SOP

i) Choose any 4 products and verify the status of BMRs

iii) Check the BMRs for any deviation or discrepancy

Is the current list of loan license / contract manufactures available

i) Is the name of contact person given with address and telephone numbers.

ii) Are loan license / contract manufactures approved by QA. Verify the records


Human Resources (HR)


Verify if the list of employees is current
Is there a SOP for induction program of new recruits, Check records
Verify if responsibilities of key personnel’s are clearly designated and documented
Check induction and medical records of new joinee Select any 2 or 3 employees
Check the availability of a qualified medical practitioner
Mention the schedule for medical examination
Choose 2-3 employees from each section/dept. verify the following: Health records, medical leave records
Verify whether a system exists for re-examination of an employee returning after a long medical leave by the company designated medical practitioner
Is the training imparted for SOPs, GMP etc.

i)  Check staff training records

ii) Check external trainers record and verify the attendance through staff training records

iii) Is the training literature and material preserved

Have employees’ undergone training on GMP, SOP and on job requirements, Are records available?
Verify training recording of three personnel.
SOP and training of personnel available. Is the relevant information like study material, attendance record, evaluation record, re-training record etc. available.
Is the list of current technical persons available
Is a list of personnel and the responsibilities available
Is the first aid box provided at all the key locations
Premises including personnel facilities & Sanitation / Housekeeping
Is the facility maintained in a clean and sanitiric condition
Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control
Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)
Verify, if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures
Does the facility have written procedures for the safe and correct use of cleaning sanitizing agent
Does the solution of cleaning and sanitation indicate rotation of Disinfectant If yes, check disinfectant inventory/ stock
Check if cleaning records are maintained
What is the level hygiene: Good (G)/Excellent (E)/Satisfactory (S)/Bad (B) (especially check nail, hair, etc.)
Is each workers provided with two sets of uniforms/apparel Check records
Are the gowning and degowning SOPs available and properly displayed in the change room
Are the designated change rooms maintained properly and are provided with facilities like washrooms, swing-over benches, light, ventilation etc.
Is there a fixed schedule for washing of uniform Check records
Are the workforce trained in personnel Hygiene is the training documented
Is the canteen or eating room facility neat and clean
Check if fire extinguishers are installed, checked, properly   labeled and are fire safety drills performed as per schedule
Is written procedure describing safety measures is available
Are lighting and ventilation adequate to facilitate comfortable working
Check if the emergency exits in the building are maintained and unobstructed
Check if toilet cleaning and maintenance record are maintained, Availability of soap, hot and cold water air dryers, single service towels
Is waste being segregated as – plastics, organic, metal etc.
Maintenance of buildings and Equipment’s / Engineering Services


Are written procedure established for maintenance of equipment and utilities
Are utilities maintain and monitored as per schedule
Is the preventive maintenance of major utilities being performed

a) Air Handling Units (AHUs)

b) Compressed Air

c) Vacuum

d) Air Conditioners

e) Chiller Plant

f) Light Fittings

     g) DG sets

Does the filters in compressed air units are cleaned as per schedule Check the SOP
Does the filters and prefilters in AHU system are cleaned as per schedule Check the SOP
Is the cleaning procedure available for

a) Cooling towers

b) Chiller plant

c)  Air handling units / duct / dampers

d) Raw / DM Water storage tanks

Are the service pipes clearly marked & indicate direction of flow (air, water, vacuum, LPG, Compressed Air)
Is there a schedule for the maintenance of service pipes. If yes, check the records.
Is there a SOP on building maintenance. If yes, check the records
Does calibration planner is available and check for the compliance
Is the list of critical spare parts for all the machines / equipment’s available

i) Check the list of critical spares for equipment; one each from production and utility

ii) Check the stock ledger for the spare parts

Is the validation / calibration of equipment’s / gauges performed as per schedule i) Check the validation / calibration records of three equipment




Is the annual maintenance contract (AMC) / agreement available for the equipment which are not covered under preventive maintenance schedule
Check the record for job orders received and executed
Production & Equipment


In case of any environmental failures, the concerned department been intimated for corrective actions, are all such actions documented?
Are the weighing balances calibrated check records
Does all equipment’s used for manufacturing / processing are suitable in their size / capacity
Are the location of the equipment / machines in the facility Acceptable?
Is there adequate space for the following equipment’s? blender(s) dryer, compression machine(s) capsule fillers, bottle fillers etc.
Are the equipment / machines properly design and installed
Are machine surfaces that contract materials or finished goods non-reactive, non-absorptive and non-adaptive so as not to affect the product
Is the ideal equipment stored in a designated area
Is equipment cleaned promptly after used
Are written operating procedures available for each equipment used in manufacturing / processing or holding of components, in process material or finished product
Does the startup procedure ensure that equipment is thoroughly cleaned
Are all equipment’s have an identification no.
Do the major equipment have usage logs, cleaning logs, preventive maintenance logs
Are the relevant components of the machines calibrated and records maintained
Are monitoring devices like thermometers, hygrometers installed, calibrated and functional
Does the filters in the inlet of FBD are cleaned as per schedule

Check the SOP

Production and In-process Control
Is the entry to the production area restricted
Are the work force trained in gowning / degowning / personnel hygiene / SOP / GMP etc.? Check compliance to SOP
Are production personnel attired as per SOP
Does complete set of SOPs available. Is it current?
Verify the list of equipment and their identification codes
Is the BMR approved by QA prior to circulation
Check a current batch record from the shop floor
Are raw and packaging material tags attached in the BMR
Are the environmental conditions in different areas being monitored, maintained and recorded?
In case of failure is the concerned department informed. Are the corrective actions documented
Is the impact of such environmental failure evaluated for impact on product
Is the procedure for line purging or line clearance followed? Question people regarding pack up at the end of shift or otherwise
Are the line clearance or line purging records being attached with the respective BMR
Does the machine indicate batch details and stage of processing of the batch
Are the in process checks being verified by IPQC personnel along with production personnel
Are the technical directions being followed and entries being made in it, simultaneously
Is there a procedure for issue, use and destruction of rubber stereos for coding during labeling and packing operations
Before the start of coding, are all specimens approved by IPQC
Are the approved specimen attached in the BMR of the product
How are coded unused material handled. Ask the workforce and packing supervisor
Are the labeling and packaging lines appropriate
Are there any physical separation between packaging lines
Is one product being processed in particular area
Is the wash water concept used for equipment
Are the washed and cleaned containers and machinery stored properly when not in use
Is the procedure for process deviation implemented? Check records
Quality Control


Is the lab neat and orderly with enough space for working space
Lab Reagents:

i) Reagents bottles properly labeled (Name, date of preparation, use before date, prepared by)

ii) Reagents bottle properly closed

iii) Placed as per temperature requirements

Is there a ledger maintained for stock of chemicals and media
Is there proper storage area with different chemicals differentiation
Instrument Calibration / Maintenance

i) Check out three instruments, check calibration SOP and records

ii) Is there a specific program schedule of calibration

iii) Where external standards are used verify their reliability

iv) All the instruments been calibrated in the operational range

Testing and Analysis

i) Are all tests being performed as per Standard Test Procedure

ii) Are the testing report signed and dated by analyst

iii) Are the testing records counter checked by QC in-charge before release of sample

iv) Is there a SOP on out of specification results

Is entry to laboratory restricted
Are the standard bacterial cultures available
Is the bacterial passing record available
Is the SOP for cleaning validation  available for general and aseptic areas
Is gowning and degowning SOP available for aseptic area
Is there a SOP for fumigation for aseptic area
Is there a SOP for cleaning and operation of LAF
Are the cleaning and operation checks implemented and recorded
Is there an SOP describing preparation, usage and discarding of used cultured media
Internal Audit Report
Internal Audit Planner
Frequency of Internal Audits
Internal Audit Register
Flow Chart for Internal Audit


Management of Clinical Supplies

About Pharmaguidanaces Channel

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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