Documentation for Manufacture of Sterile products The manufacturing records relating to manufacture of sterile products shall indicate the following details: – (1) Serial number of the Batch Manufacturing Record. (2) Name of the product. (3) Reference to Master Formula Record. (4) Batch / Lot number. (5) Batch / Lot size. (6) Date of commencement of…
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In-process Checks during Tertiary Packaging Operations of cartons/ shrink-wrapped units in one corrugated box / LDPE bag: Count the no. of cartons / shrink wrapped units in one corrugated box / LDPE bag and verify with the Batch Packing Record. Stencil on corrugated boxes: Check the stencil details on the corrugated boxes. Insertion of Packer’s…
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In-process Checks during Secondary Packaging Operations Performed in In-process quality checks as pre-defined frequency in BPR and to be sorted out the strips/blister with below-mentioned tablet defects before packed in carton or during Packing Broken Tablets Laminated Tablets Chipped Tablets Discoloured Tablets With Black particles Tablets With foreign particle Tablets Distorted Tablets Improper Batch coding…
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In-process Checks during Primary Packaging Operations (Blister / Strip Packing) Record the temperature and relative humidity of the Packaging area. Tablets and Capsules: Following defect /Issue to be sorted out before strip/blister sealing Broken Tablets Laminated Tablets Chipped Tablets Discoloured Tablets With Black particles Tablets With foreign particle Tablets Distorted Tablets Foil shifting: Foil shifting…
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Optimal HVAC Systems for Non-Sterile Pharmaceutical Environments: Ensuring Quality and Compliance In the pharmaceutical industry, maintaining a controlled environment is crucial to ensure product quality, safety, and regulatory compliance. HVAC (Heating, Ventilation, and Air Conditioning) systems play a vital role in non-sterile pharmaceutical facilities by providing appropriate temperature, humidity, and air quality control. These systems…
Temperature mapping of storage areas: Ensuring Reliable Environmental Control and Compliance In various industries, maintaining proper temperature control within critical areas is essential to ensure product quality, integrity, and regulatory compliance. Temperature mapping of storage areas is a systematic process that involves monitoring and analyzing temperature distribution within a defined space, such as a storage…
Observations & Compliances response of GMP Inspections Observations 1: In the DM water plant, there were no records maintained for the change of air filters from the compressor to the degasser. Response: The procedure for the replacement of filters has been incorporated in the SOP for the replacement of cartridge filters. A format is also…
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Organization and Personnel Responsibilities of quality control unit. (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred…
The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory. Anvisa’s role it to promote the protection of the population’s health by executing sanitary control of the…
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Vial Washing Machine: Streamlining Sterile Pharmaceutical Packaging In the pharmaceutical industry, maintaining the integrity and cleanliness of packaging materials is crucial for ensuring the safety and efficacy of drugs. Vial washing machines play a vital role in the production of sterile pharmaceuticals by efficiently cleaning and sanitizing vials before they are filled with medications. These…
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New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable to pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data for DCGI permission. Head, RA…
Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. Objective To lay down a procedure for the Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for preparation and implementation of Technical Directions for all products manufactured at all pharmaceutical…
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Un-Planned Deviation Details for Deviation No.______________ Department : Production Investigation starts date: Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1. Production Head Production 2. Production Manager Production 2. Engineer Technologist Production 4. QA Officer Quality Assurance 5. QA Head Quality Assurance Sr. No. Product Batch No. BMR Reference Number …
Un-Planned Deviation – II in Pharma Details for Deviation No. ________ Department : Production Investigation start date : Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1. Production Head Production 2. Production Manager Production 2. EngineerTechnologist Production 4. QAOfficer Quality Assurance 5. QA Head Quality Assurance Sr.No. Product Batch No. BMR…
Un-Planned Deviation in Pharma Investigation Report Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators. Type of deviation: Un-Planned Deviation Class of Deviation: Minor Date of investigation: Department: Warehouse Date of deviation Observed: Investigations start date: Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1….
List OF SOPs ENGINEERING S. No. SOP Title 1. Preventive Maintenance 2. Breakdown Maintenance Procedure of the Equipment and Machines 3. Colour Coding of Utility Lines 4. Procedure for Building Maintenance 5. Calibration of Equipment and Instrument from External Authorized Body / Suppliers 6. Operating procedure of Vacuum Circuit Breakers and Transformers 7. Changeover from…
List of SOPs of Environment, Occupational Health, and Safety (EOHS) S. No. SOP Title 1. Operating procedure for Effluent treatment plant 2. Procedure for analysis of treated effluent 3. Procedure for operation and calibration of Tds meter in ETP laboratory 4. Calibration and Operating procedure for pH meter 5. Operating procedure of BOD Incubator in…
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Warehouse (Stores) Warehousing is a complex and dynamic field that plays a critical role in maintaining the integrity and safety of products. Adhering to regulatory standards, and implementing best practices, Warehouses or stores can contribute to the overall efficiency of the supply chain. The Importance of Warehousing: Warehouses or stores serve as the central hub…
HR SOPs (Human Resources) S. No. SOP Title 1 Medical Examination 2 Personnel clothing and Hygiene 3 First Aid Procedures 4 Accident management Procedures 5 Preparation of Job responsibilities 6 Training of Personnel s 7 Scrap Management and Disposal 8 Cleaning and Sanitation of General Area 9 Cleaning and Classification of Dustbins 10 Safety Measures…
SOP LIST (Quality Assurance) S. No. SOP Title 1. Preparation, Approval, and Control of Standard Operating Procedures 2. Vendor Approval 3. Change Control 4. Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. 5. Preparation, Approval and Control of Specifications and Standard Test Procedures for Raw Materials, Packaging Materials,…
