sop for self inspection and internal audit for quality
1.0 OBJECTIVE: The objective of this SOP is:
1.1 To laid down the procedure to conduct self-inspection (Internal Audit) in order to monitor the implementation and
compliance with Good Manufacturing Practices (GMP), Principles and to propose necessary corrective measures.
2.0 RESPONSIBILITY:
2.1 The Audit Team shall be:
2.1.1. Responsible for conducting the audit as per schedule
2.1.2. Responsible for checking the compliance of observations made in the previous audit.
2.1.3. Responsible for Preparation of Self-Audit Report.
2.2 The Executive – Quality Assurance shall be:
2.2.1 Responsible for preparation of Annual Calendar for Self-audit.
2.2.2 Compilation of Self-Audit reports and compliance report.
2.2.3 Preparation of Summary Report of the Self -Audit at the end of Year.
2.3 The Head – Quality Assurance shall be:
2.3.1 Responsible for approval of Annual Calendar for Self-audit.
2.3.2 Responsible for ensuring the conduction of self-audit as per schedule.
2.3.3 Responsible for review and approval of summary report of self-audit reports.
2.4 The Auditee shall be:
2.4.1 Responsible for implementing the corrective action recommended by Audit Team
2.4.2 Responsible for preparation of Audit Compliance report.
2.4.3 Responsible for conducting the audit as per schedule with Audit Team.
3.0 ACCOUNTABILITY:
Head – Quality Assurance
4.0 PROCEDURE:
4.1 Annual calendar for self-audit shall prepare and Approve for the forthcoming
year at the end of current Year (Refer Annexure –1).
4.2 In the self-audit, the compliance of previous self-audits / external audits shall be checked.
4.3 During Self Inspection also check the compliance level of audits done by any
External Agency or any regulatory body. Also access the compliance level of audit Carried out by customers.
4.4 Each of the areas shall be inspected and audited as per Annual Calendar Schedule.
4.5 The list Auditors (Annexure –2) has been prepared from different departments.
4.6 Identified Audit Team for different areas. (Refer Annexure – 3)
4.7 Each area shall be audited/inspected on Quarterly basis. The parameters to be covered
shall include compliance with cGMP, cGLP, cGWP and Safety etc..
4.8 The audit scope may be narrowed down to cover only a particular segment/ activity.
4.9 The auditors shall jointly inspect the respective areas as per checklist (Refer Annexure – 5)
4.10 The observations may not be strict & limited to the checklist.
4.11 The auditor’s report shall be agreed on findings based on factual evidence. It is necessary to record.
4.12 The deficiencies observed shall be categorised as Critical, Major, and Other deficiencies.
4.13 Minor: Deviation for standard operating procedure or cGMP violation,
which cannot lead to what is described under Major and Critical.
4.14 Major: Any deviation from the validated / established procedure, process, system and practices.
4.15 Critical: Critical point is any Non conformance, which can affect the purity and strength
and safety of the medicine, which may pose serious health risk to the user.
4.16 Based on the observations in the audit, the Auditor shall prepare the audit report
as per the format given in Annexure – 4 and send a copy of the same to the Auditee, within 15 days of audit date.
4.17 A copy of Audit Report shall be submitted to Head – Quality Assurance.
4.18 The audited department shall send their compliance plan within 15 days with target
date (if applicable) for implementation to the Audit team.
5.0 REASON FOR REVISION:
The SOP is revised to include additional checkpoints on aseptic behavior as well as aseptic
practices in the self-audit checklist of injection Manufacturing facility.
6.0 TRAINING:
Trainer — Head – Quality Assurance
Trainees — All Departmental Heads
Period — One day
7.0 DISTRIBUTION:
Certified Copy No. 1 : Head of Department – Quality Control (Chemical)
Certified Copy No. 2 : Head of Department – Quality Control (Micro)
Certified Copy No. 3 : Head of Department – Engineering
Certified Copy No. 4 : Head of Department – Warehouse
Certified Copy No. 5 : Head of Department – Personnel and Administration
Certified Copy No. 6 : Head – Plant Operations
Original Copy : Head – QUALITY ASSURANCE.
8.0 ANNEXURES:
Annexure – 1 : Annual Calendar of Self-Audit Report
Annexure – 2 : List Of Auditors
Annexure – 3 : List of Department wise Auditors
Annexure – 4 : Format for Audit Report and Compliance Report
Annexure – 5 : Check List for Self-Audit.
9.0 REFERENCES:
In-house
ANNEXURE – 1
FORMAT FOR ANNUAL CALENDAR OF SELF-AUDIT
| Sr. No. | Departments | Jan. | Feb. | Mar. | Apr. | May. | Jun. | Jul. | Aug. | Sep. | Oct. | Nov. | Dec. |
| 1. | Raw Material Store | 1st week | 1st week | 1st week | 1st week | ||||||||
| 2. | Packaging Material Store | 1st week | 1st week | 1st week | 1st week | ||||||||
| 3. | Engineering | 4th week | 2nd week | 2nd week | 2nd week | ||||||||
| 4. | Oral Manufacturing | 1st week | 1st week | 1st week | 1st week | ||||||||
| 5. | Injection Manufacturing | 1st week | 1st week | 1st week | 1st week | ||||||||
| 6. | Bonded Store Room | 1st week | 1st week | 1st week | |||||||||
| 7. | Quality Control | 1st week | 1st week | 1st week | |||||||||
| 8. | Quality Assurance | 1st week | 1st week | 1st week | |||||||||
| 9. | Personnel & Administration | 2nd week | 2nd week | 2nd week |
ANNEXURE – 2
LIST OF AUDITORS
| Sr. No. | Name of Auditor | Department |
| 1. | Technical Operation | |
| 2. | Plant Operation | |
| 3. | Quality Assurance | |
| 4. | Engineering Services | |
| 5. | Production –General Block | |
| 6. | Production – C Block | |
| 7. | Production – C Block | |
| 8. | Warehouse | |
| 9. | Warehouse | |
| 10. | Quality Control | |
| 11. | Quality Assurance | |
| 12. | Quality Assurance | |
| 13. | Quality Control –
Microbiology |
|
| 14. | Production – General Block |
ANNEXURE – 3
LIST OF DEPARTMENT WISE AUDITORS
| Sr. No. | Name of Department | Name of Auditors |
| 1. | Raw Material Store | |
| 2. | Packaging Material Store | |
| 3. | Engineering Services | |
| 4. | C-Block Oral Manufacturing | |
| 5. | C-Block Injection Manufacturing | |
| 6. | General Block Oral Manufacturing | |
| 7. | General Block Injection Manufacturing | |
| 8. | Bonded Store Room | |
| 9. | Quality Control | |
| 10. | Quality Assurance | |
| 11. | Personnel & Administration |
ANNEXURE – 4
FORMAT FOR AUDIT REPORT AND COMPLIANCE REPORT
1) POINTS CONTINUED FROM LAST AUDIT FOR CHECKING OF COMPLIANCE
| Sr. No. | Category | Observations | Status |
| 1.1 | |||
| 1.2 | |||
| 1.3 | |||
| 1.4 |
2) CURRENT OBSERVATIONS
| Sr. No. | Category |
Observations |
Agreed corrective actions | Target Completion date | Remarks |
ANNEXURE – 5
AUDIT CHECKLIST
| S. No. | Check Points | Yes / No | Remarks |
1.0 Departmental Organogram
2.0 Job responsibilities defined in writing for:
2.1 Managers
2.2 Supervisors
2.3 Workers
3.0 Training Programme
3.1 Calendar for annual Training for staffs and workers
3.2 Training Matrix
3.3 Template of Questionnaire (True / False, Multiple choice, fill in the blanks and descriptive questions)
3.4 Evaluation standards and retraining
4.0 Flow Chart With Major Processing Steps
5.0 Condition of garments and uniforms
6.0 Sufficient number of clean uniform available
7.0 The normal range of uniform includes
7.1 Caps or hair covers
7.2 Beard and moustache covers / nose masks
7.3 Factory foot wears
7.4 Safety glasses/protective glasses
7.5 Personnel belongings are not brought in production area.
7.6 Gowning and degowning procedure
8.0 Building and facilities
8.1 Are all parts of the facility constructed in a way that makes them suitable for the manufacturing, testing and holding of drug products?
8.2 Is there sufficient space in the facility for the type of work and typical volume of production? Check devices on floor / ceiling / walls / door glasses / are intact.
8.3 Does the layout and organization of the facility prevent contamination?
9.0 Safety, Facility maintenance and Good Housekeeping Program
9.1 Emergency exit – any obstacles in the way and way to exit is clear
9.2 Fire extinguishers are in working condition or not?
9.3 In First Aid Box sufficient medici9nes available or not.
9.4 Program for infestation by rodents and pest control?
9.5 Written procedures for the safe use of suitable, rodenticides, insecticides, fungicides and fumigating agents?
9.6 Written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material?
9.7 Pre-filter cleaning records and frequency
9.8 FBD / Coater, HEPA integrity testing and records available
9.9 Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents?
9.10 Is lighting is adequate in all areas?
9.11 Is adequate ventilation provided?
9.12 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage and testing of drug products?
9.13 Records of repairs kept
9.14 FBD bags product dedicated / cleaning storage / identification.
9.15 Mock drill in Case of Fire and Accident
10.0 Equipment design and Placement
10.1 Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its intended use?
10.2 Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet,
Presses, Capsule Fillers, Bottle Fillers, Other (specify).
10.3 Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s),
Tablet Presses, Capsule Fillers, Bottle Fillers, Other (specify).
10.4 Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s),
Tablet Presses, Capsule Fillers, Bottle Fillers, Other (specify).
10.5 Are the locations in the facility of the following pieces of equipment acceptable?
Blender(s), Conveyor(s), Tablet Presses, Capsule Fillers, Bottle Fillers, Other (specify).
10.6 Are the following pieces of equipment properly installed? Blender(s), Conveyor(s),
Tablet Presses, Capsule Fillers, Bottle Fillers, Other (specify).
10.7 Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s),
Tablet Presses, Capsule Fillers, Bottle Fillers, Other (specify).
10.8 Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive,
and non-additive so as not to affect the product?
10.9 Are designs and operating precautions taken to ensure that lubricants or coolants or other
operating substances do NOT come into contact with drug components or finished product?
10.10 Is each idle piece of equipment clearly marked “needs cleaning” or “Cleaned; “Ready for Use”?
10.11 Is equipment cleaned promptly after use?
10.12 Is idle equipment stored in a designated area?
10.13 Are written procedures available for each piece of equipment used in the manufacturing,
processing or holding of components, in-process material or finished product?
10.14 Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly cleaned?
11.0 Equipment Identification
11.1 Are all pieces of equipment also marked with an identification number that corresponds with
an entry in an equipment log? (Dies, punches, Inspection sets, sieves, screens, packaging machines / change parts)
11.2 Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance?
11.3 Is the maintenance log for each piece of equipment kept on or near the equipment?
11.4 Has the cleaning procedure been properly validated?
11.5 If appropriate, is the equipment sanitized using a procedure written for this task?
11.6 Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?
11.7 Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment?
12.0 Equipment Qualification Program
12.1 Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results.
12.2 When computers are used to automate production or quality testing, have the computer and software been validated?
12.3 Have on-site tests of successive production runs or tests been used to qualify equipment?
12.4 Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum
operating speeds for valid results?
12.5 Have operating limits and tolerances for performance been established from performance characteristics?
12.6 Instruments/gauges used along with the equipment are calibrated and records maintained
12.7 Status labels become a part of the BPR
13.0 Material / Component Control
13.1 Proper segregation of received RM form warehouse.
13.2 Is each lot within each shipment of material or components assigned a distinctive
code / identification so material or component can be traced through manufacturing and distribution?
13.3 Does inspection start with visual examination of each shipping container for appropriate
labeling, signs of damage, or contamination?
13.4 Is the sampling technique written and followed for each type of sample collected?
13.5 Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is required?
13.6 Proper segregation of Inprocess material
13.7 Proper segregation of manufactured, checked/sorted and packed materials.
13.8 Separate area available for packed finished goods awaiting transfer to finished goods warehouse.
13.9 Quarantine for unreleased packed finished goods.
14.0 Equipment / Line / Area Cleaning, Preparation and Clearance
14.1 Do written procedures detail how equipment is to be checked immediately prior to use for cleanliness,
removal of any labels and labeling from prior print operations?
14.2 Do written procedures detail any disconnection and reassembly required to verify readiness for use?
15.0 Process Validation and Production Change Control
15.1 Have production procedures been validated? (Review selected procedures for validation documentation. Adequate?)
15.2 Does the process control address all issues to ensure identity, strength, quality and purity of product?
15.3 Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients?
15.4 Have records indicated preceding policy been followed by presence of two signatures?
15.5 Are actual yields calculated at the conclusion of appropriate phases of the operation and at the end of the process?
16.0 In-Process Inspection, Sampling, and Laboratory Control
16.1 Are written procedures established to monitor output and validate the performance of manufacturing procedures that may cause variability in characteristics of in-process materials and finished drug products?
16.2 Is in-process materials tested at appropriate phases for identity, strength, quality and purity and are they approved or rejected by Quality Control?
16.3 Are there laboratory controls including sampling and testing procedures to assure conformance of components,
containers, closures, in-process materials, and finished product specifications?
16.4 Are the instruments in in-process laboratory calibrated or not?
17.0 Finished Product Inspection, Sampling, Testing, and Release for Distribution
17.1 Has the formulation for each product been tested for stability based on a written protocol?
17.2 Are written sampling and testing procedures and acceptance criteria available for each
product to ensure conformance to finished product specifications?
17.3 Is a quantity of samples equal to at least twice the quantity needed for finished product
release testing maintained as a reserve sample?
17.4 Inprocess examination results are kept in BPR / BMR
17.5 Expiration dates appear on the labeling in accordance with the requirements of the law
18.0 Sewage and refuse
18.1 Sewage, trash and other refuse in and from the building and immediate premises is disposed
off in a safe and sanitary manner.
19.0 Washing and toilet facilities
19.1 Adequate washing facilities are provided which includes, – Water – Soap/detergent
20.0 3 Time limitations on production
20.1 Time limitations for completion of each phase of production are available and followed.
20.2 Deviations, if any, are justified and documented
21.0 Reprocessing
21.1 Written procedure exists for reprocessing of batches
21.2 All reprocessing are documented
21.3 Reprocessing is done only after approval of QA. Investigation and preventive action for future.
22.0 Documents
22.1 Stage wise completion of BMR, BPR & related records.
22.2 Self inspection reports available
22.3 Inprocess specifications available
23.0 3 Following SOPs are available
23.1 SOP on SOP
23.2 Self Inspection
23.3 Deviation, NCR and Change Control Procedure
24.0 4 Packaging and labeling operations
24.1 Written procedures and adequate control exist to assure that correct labels and
labeling and packaging materials are used.
24.2 Bulk products, Inprocess and packing materials are well controlled.
24.3 Packed goods awaiting transfer to FG warehouse are well segregated.
24.4 Suitable dust extraction and hoppers are well closed and correctly identified
24.5 Bulk material containers and hoppers are well closed and correctly identified.
24.6 Line clearance exercised before starting the packing operation.
24.7 During lunch and tea breaks and shift closure protection of material.
24.8 Packing lines are having line boards prominently displayed to indicate current operation.
24.9 Reconciliation of Packing materials
25.0 Procedure in case of power failure