Manufacturing:Issuance of BMR and Label claim is proper. All the pages are available and comply with the index. Manufacturing and expiry are correctly alloted. Dispensing is carried out on calibrated balance. Raw Material Requisition is available. Coating Material Requisition is available. Line clearance is taken prior to all dispensing and manufacturing activities. Dispensing is carried out as p…
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Checklist for Batch Review in Liquid Manufacturing
ManufacturingIssuance of BMR and Label claim is proper.All the pages are available and comply with index.Manufacturing and expiry are correctly alloted.Dispensing is carried out on calibrated balance.Raw Material Requisition is available.Line clearance is taken prior to all dispensing and manufacturing activities.Dispensing is carried out as per work order.
Raw Material Assessment Sheet is availab…
Raw Material Assessment Sheet is availab…
Checklist to Receive the RM/PM
1. All necessary and relevant documents are received.
2. The vehicle is free from any oily, grease, dyes or any foreign materials.
3. Manufacturer’s / Supplier’s labels are visible and approachable.
4. All relevant details like Name, B. No., Mfg. and exp. Dates, storage Condition are mentioned on labels.
5. The material is received from the vendor listed in the approved vendor list.
6. All contai…
2. The vehicle is free from any oily, grease, dyes or any foreign materials.
3. Manufacturer’s / Supplier’s labels are visible and approachable.
4. All relevant details like Name, B. No., Mfg. and exp. Dates, storage Condition are mentioned on labels.
5. The material is received from the vendor listed in the approved vendor list.
6. All contai…
Checklist for Audit in IT
Checklist for preparation of audit in information technology (IT) department in a pharmaceutical facility.
1. Is the list of Software installed in equipment and instruments is available?
2. Are the certificates for all installed software available?
3. Are the CDs for software available and stored properly?
4. Is the list for PCs available?
5. Is the backup of data taken as per schedule? Check the…
1. Is the list of Software installed in equipment and instruments is available?
2. Are the certificates for all installed software available?
3. Are the CDs for software available and stored properly?
4. Is the list for PCs available?
5. Is the backup of data taken as per schedule? Check the…
Checklist for Audit in Sterile Area
Checklist to verify the sterile manufacturing area before the audit.
1. Is there any SOP giving details for activity/ movement in the sterile area.
2. Verify the suitability of the system for sanitization of hands.
3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available?
4. Verify the availability of the following records:
Air pressure differentialParticulate mon…
1. Is there any SOP giving details for activity/ movement in the sterile area.
2. Verify the suitability of the system for sanitization of hands.
3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available?
4. Verify the availability of the following records:
Air pressure differentialParticulate mon…
Checklist to Review Tablet Process Validation
Checkpoints to review the process validation for the tablet manufacturing process.
1. Is the reason for the presence of each ingredient in the formula provided?
2. Are the normal properties of each ingredient mentioned? Are these properties used or changed in the formula under study.
3. Are the characteristics of the initial powder blends, the wet and/or dry granulations and the final blends ment…
1. Is the reason for the presence of each ingredient in the formula provided?
2. Are the normal properties of each ingredient mentioned? Are these properties used or changed in the formula under study.
3. Are the characteristics of the initial powder blends, the wet and/or dry granulations and the final blends ment…
Checklist for Audit in Safety and Environment Department
1. Are the Safety, Health and Environment Policy available?
2. Is the list of safety equipments available?
3. Check the training schedule for safety for the location. Is it available?
4. Check the record for accidents and verify the action taken.
5. Check the list of safety boxes. Is it updated/
6. Check any safety box – are the safety items like – nose mask, gloves etc. available. Is the ma…
2. Is the list of safety equipments available?
3. Check the training schedule for safety for the location. Is it available?
4. Check the record for accidents and verify the action taken.
5. Check the list of safety boxes. Is it updated/
6. Check any safety box – are the safety items like – nose mask, gloves etc. available. Is the ma…
Checklist for Audit in Purchase Department
Checklist to verify the documents of the purchasing department before an audit.
1. Is the current list of Vendors available?
2. Is the list of TSE / BSE certificates available?
3. Verify the addresses of manufacturers/suppliers from the current vendor list. Is it concurrent?
4. Check the Purchase Orders for SAP codes. Are the SAP codes current and approved?
5. Check the Purchase Orders from vendo…
1. Is the current list of Vendors available?
2. Is the list of TSE / BSE certificates available?
3. Verify the addresses of manufacturers/suppliers from the current vendor list. Is it concurrent?
4. Check the Purchase Orders for SAP codes. Are the SAP codes current and approved?
5. Check the Purchase Orders from vendo…
Checklist for Audit in Ointment Manufacturing
Checklist for the inspection of the ointment manufacturing facility. Audit your ointment manufacturing facility with this checklist to find the problems that can compromise the product quality.
Contents:
A. Premises, Facility and Personnel Hygiene
B. Dispensing of Raw Materials
C. Manufacturing
D. Equipment
E. Packing
A. Premises, Facility and Personnel Hygiene 1. Is the Site suitable for manufa…
Contents:
A. Premises, Facility and Personnel Hygiene
B. Dispensing of Raw Materials
C. Manufacturing
D. Equipment
E. Packing
A. Premises, Facility and Personnel Hygiene 1. Is the Site suitable for manufa…
Checklist for Audit in Quality Control
1. Whether adequate facilities, trained persons and approved procedures are available?
2. Is there an organized and documented system for specification, sampling, testing and release of materials and products?
3. Is there a system for approval or rejection of materials and products?
4. Whether quality control is involved in all the decisions concerning the quality of the product?
5. Is there a m…
2. Is there an organized and documented system for specification, sampling, testing and release of materials and products?
3. Is there a system for approval or rejection of materials and products?
4. Whether quality control is involved in all the decisions concerning the quality of the product?
5. Is there a m…
Checklist for Audit in Environment, Health and Safety (EHS)
1. Is SOP Index available?
2. Is there any obsolete SOP available in the file?
3. Is drawing showing the positions of water hydrant points available in the department?
4. Is drawing showing the positions of wall-mounted fire extinguishers available in the department?
5. Are records for BOD, COD for ETP available in the department?
6. Are there any excursions in the BOD, COD records w…
2. Is there any obsolete SOP available in the file?
3. Is drawing showing the positions of water hydrant points available in the department?
4. Is drawing showing the positions of wall-mounted fire extinguishers available in the department?
5. Are records for BOD, COD for ETP available in the department?
6. Are there any excursions in the BOD, COD records w…
Checklist for Internal Audit or Self Inspection Defects and Regulatory Compliance
Following types of defects were identified during an internal audit and these are helpful in regulatory compliance:
1. Critical defect:
Critical defects have a high probability of resulting in a product recall or in an adverse physiological response by the consumer. Critical deficiencies found in internal audits that usually produce significant effects on the strength, identity, safety and purity o…
1. Critical defect:
Critical defects have a high probability of resulting in a product recall or in an adverse physiological response by the consumer. Critical deficiencies found in internal audits that usually produce significant effects on the strength, identity, safety and purity o…
Checklist for Audit in HR/ Admin
Checklist for preparation of audit in human resource/ admin department.
1. All the personnel is aware or trained to understand the principles of GMP.
2. Whether the organization chart/organogram is in place?
3. Whether the responsibilities at different levels are clearly defined?
4. Whether unauthorized personnel is restricted to enter the premises?
5. Whether training programs are conducted fo…
1. All the personnel is aware or trained to understand the principles of GMP.
2. Whether the organization chart/organogram is in place?
3. Whether the responsibilities at different levels are clearly defined?
4. Whether unauthorized personnel is restricted to enter the premises?
5. Whether training programs are conducted fo…
Checklist for Audit in Warehouse
Checklist to prepare for audit in warehouse/ stores.
1. Whether the storage area is adequately designed for better storage conditions? (i.e. temperature, light, humidity & cleanliness). Whether Cleaning record is maintained or not.
2. Is there adequate space for the orderly storage of all starting materials, intermediates, bulk, finished product, and also a product in quarantine, released, re…
1. Whether the storage area is adequately designed for better storage conditions? (i.e. temperature, light, humidity & cleanliness). Whether Cleaning record is maintained or not.
2. Is there adequate space for the orderly storage of all starting materials, intermediates, bulk, finished product, and also a product in quarantine, released, re…
Checklist for Audit in Regulatory Affairs
Pick any product randomly and check the details.
1. Whether the specification for product / API matching with the submission?
2. Analytical method is matching with the submissions?
3. Are specifications and test procedures are available for:
Raw MaterialPackaging MaterialIn-processIntermediates 4. Are matching with the claims made in the submissions and compliance file?
5. Check the Manufacturin…
1. Whether the specification for product / API matching with the submission?
2. Analytical method is matching with the submissions?
3. Are specifications and test procedures are available for:
Raw MaterialPackaging MaterialIn-processIntermediates 4. Are matching with the claims made in the submissions and compliance file?
5. Check the Manufacturin…
