Tag Archives: Somer

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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   …

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 …

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 …

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 …

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 …

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 …

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 …

SOP on Sampling of Raw Material Objective: To lay down the procedure for the sampling of raw material. Scope: This procedure is applicable for the sampling of raw material. Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after …

List of SOPs Quality Control Sr. No. SOP Title 1. SOP on entry & exit procedure in Quality Control Department 2. SOP on sampling of raw material. 3. SOP on intermediate and finished product analysis and approval 4. SOP on analysis of sample by contract laboratory 5. SOP on sampling …

ICH Q8/Q9/Q10 1.1 For General Clarification Date of Approval Questions Answers 1.0 June 2009 Is the minimal approach accepted by regulators? Yes. The minimal approach as defined in Q8(R2) (sometimes also called ‘baseline’ or ‘traditional’ approach) is the expectation that is to be achieved for a fully acceptable submission. However, …