Tag: Springfield
Changes as per SUPAC Guideline Part -I (components or composition)
Changes as per SUPAC Guideline Part -I (components or composition) During the post-approval period, to change: 1) The components or composition 2) The site of manufacture 3) The scale-up/scale-down of manufacture. 4) The manufacturing (process and equipment) of an immediate release oral formulation. The guidance defines: 1) Levels of change 2) Recommended chemistry,manufacturing, and controls…
Operational Qualification of Fluid Bed Processor In Pharma
Operational Qualification of Fluid Bed Processor In Pharma Operational qualification is the process of demonstrating that Fluid Bed Processor will function according to its operational specification in the selected environment. All the operation of Fluid Bed Processor t is verified by performing the test functions,• A conclusion is drawn regarding the operation of Fluid Bed…
Film Coating By by design of experiments
Film Coating By by design of experiments To identify and screen the critical process parameters by design of experiments and optimizing it using the “Environmental Equivalency” (EE) factor. Film-coating of tablets has many variables and the factors like core tablet composition, coating equipment, process conditions and coating suspension, influence on quality and visual appearance of…
SOP for Responsibility of Compounding Personnel in sterile preparation
SOP for Responsibility of Compounding Personnel in sterile preparation Compounding personnel is responsible for ensuring that Compounding sterile preparations (CSPs) are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper…
Documentation for Manufacture of Pharma Sterile Products
Documentation for Manufacture of Pharma Sterile Products The Documents relating to the manufacture of sterile products shall be as follows but not limited to these documents only: – (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 /…
SOP for Out of Specification (OOS)
SOP for Out of Specification (OOS) SOP for the procedure for handling, investigating, and reporting test results, which do not meet the specification. This SOP is applicable to all out of specification results during the analysis of raw materials, packaging material, finished products, stability study samples, and any unusual results observed for test parameters This…
Disposal of waste
Disposal of waste Disposal of waste means eliminating, scraping, recycling, or destroying unwanted materials known as waste that is generated from the manufacturing, packing, and warehousing of industrial pharmaceutical products. Following the correct methods for waste disposal will ensure lesser pollution and hazards to the environment. All the pharmaceutical waste shall be collected initially in…
Handling of external laboratory activities
Handling of external laboratory activities To lay down a procedure for qualifying, auditing, sending samples with reference to testing procedures, and obtaining the results for the same. This SOP is applicable to all the external laboratories to which the samples are sent for testing due to the non-availability of in-house facilities/resources. PROCEDURE The external laboratory…
Procedure of laundry
Procedure of laundry To lay down the procedure for describing the steps to be followed for laundry the uniform. This Procedure is applicable to laundry. PROCEDURE Uniforms should be transferred from the production area in special closed plastic bags separately for each section like Packing, core area, and Warehouse. Clothes should be washed in accordance…
EXCEL SHEET VALIDATION
EXCEL SHEET VALIDATION The objective of this procedure is to establish the guideline for the validation of Microsoft Excel spreadsheets use for calculating the product quality parameters. This procedure covers the validation procedure for validation of Microsoft Excel spreadsheets use for calculating the product quality parameters in QA. Procedure Spreadsheets used for simple calculations (e.g:…
CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING
CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING The objective of this procedure is to establish the guideline for the calibration of dies required for blend sampling. This SOP is applicable to dies required for a sampling of the blend for validation batches manufactured in the Pharma Industry. Procedure Take a die to be calibrated for…
HANDLING COUNTERFEIT/FALSIFIED MATERIALS
HANDLING COUNTERFEIT/FALSIFIED MATERIALS To lay down a standard procedure that describes handling counterfeit/falsified materials. Applicable for the procedure of handling counterfeit/falsified materials. PROCEDURE The received material should undergo incoming inspection. If the incoming inspection results of the materials are unsatisfactory, the QA department initiates the investigation of the case. The Authorized person prepares a report…
Technology Transfer
Technology Transfer To lay down a procedure for technology transfer of new products to be taken. The scope of this procedure is to all the new Products for which Technology has been provided by an outside party PROCEDURE Whenever any NEW PRODUCT is to be taken at Pharmaceutical Industry & the technology has been provided…
Shipping Validation
Shipping Validation Objective The objective of this study is to establish a procedure to record temperature data to ensure that transportation conditions have not adversely affected a product until it reaches the Central Warehouse when transported as per regular Shipment practice. Scope The protocol shall be applicable at the formulation Plant. The Shipping (Transportation) validation…
COATING PANS
COATING PANS CONTENTS: COATING PROCESSES TYPES OF COATING PANS CONVENTIONAL COATING PANS PERFORATED COATING PANS VALIDATION OF COATING PANS IQ OQ PQ REFERENCES Main coating processes Film coating Sugar coating Sugar coating Traditionally sugar coatings formed the bulk of coated tablets but today film coatings are the more modern technology in tablet coating. Description of…
AUTOCLAVE – MAINTENANCE AND VALIDATION
AUTOCLAVE – MAINTENANCE AND VALIDATION. INTRODUCTION An autoclave is a device to sterilize equipment and supplies by subjecting them to high pressure steam at 121° C or more. It was invented by Charles Chamberland in 1879,although a precursor known as the steam digester was created by Denis Papin in 1679. The term autoclave is also…
