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.
Objective
To lay down a procedure for periodic internal audit and self inspection, to ensure current Good Manufacturing Practices compliance.
Scope
This Standard Operating Procedure is applicable to all departments of all formulation.
Responsibility
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.
Procedure
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
Distribution
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
History
| Date |
Revision Number |
Reason for Revision |
| 00 | New SOP |
Annexure-1A
Internal Audit Checklist For Storage of Starting Materials and Finished Products (Stores)
CHECK |
| 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 ? |
Annexure-1B
Documentation / Quality Assurance
| CHECK |
| 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 |
Annexure-1C
Human Resources (HR)
CHECK |
| 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 |
Annexure-1D
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. |
Annexure-1E
Maintenance of buildings and Equipment’s / Engineering Services
CHECK |
| 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
a)………………………………………….. b)………………………………………….. c)………………………………………….. |
| 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 |
Annexure-1F
Production & Equipment
CHECK |
| 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 |
Annexure-1G
Production and In-process Control
| CHECK |
| 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 |
Annexure-1H
Quality Control
CHECK |
| 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 |
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
