ASEPTIC PROCESSES VALIDATION AS PER PIC/S

ASEPTIC PROCESSES VALIDATION AS PER PIC/S Validation of aseptic processes relies upon prospective, concurrent, and retrospective validation as well as re-validation. Prospective studies include installation and operational qualification for a new or renovated facility as well as product simulation studies and a prospective process validation with the original product according to PIC/S Document PI 006. … Read more

Tablet Defects and Remedial action in Pharma

Tablet Defects and Remedial action in Pharma In the routine manufacture of tablets, various defects are observed. The source of the problem or the defect is the formulation, the compression or coating equipment, or a combination of these. Tablet defects are deficiencies that are usually encountered in tablet formulation. Depending on experience, machinery, and excipient … Read more

Batch Manufacturing Record(BMR)

Batch Manufacturing Record(BMR) Document No Effective Date Revision No Supersedes Doc No BMR November Product Name Atorvastatin  calcium equivalent to Atorvastatin 10 mg page 1 to…. Batch No Batch Size 2000000 tablets   Product Code Composition Each film coated tablet contain Atorvastatin  calcium equivalent to Atorvastatin 10 mg MFG DATE EXP DATE SHELF LIFE BATCH … Read more

Rubber Bung Processor Cum Sterilizer

Rubber Bung Processor Cum Sterilizer • HPHV Steam Sterilizer is used for sterilization of liquid, Hard and Hard Porous Material, Glass ware, drugs and surgical instrument used a pharmaceutical. It is also used For Sterilization of containers, vessels, linen, rubber articles culture media etc. • Provide with Sliding doors with high temperature resistant silicone gaskets. … Read more

Cleaning of Factory Footwear

Cleaning of Factory Footwear Objective To lay down a procedure for Cleaning of Factory Footwear.  Scope This Standard Operating Procedure is applicable for cleaning of factory footwear in the formulation plant. Responsibility Housekeeping personnel is responsible to follow the procedure mentioned in SOP. HR Department is responsible for implementation of the procedure mentioned in SOP. … Read more

Sterilization Process Controls

Sterilization Process Controls Inspectional Objectives Confirm that the sterilization process was validated by reviewing the validation study. Review the specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process. Verify that the process is controlled and monitored. If review of the Device History Records (including process control and monitoring … Read more

Dry Powder Injection

Dry Powder Injection Majority of drugs show the problem of poor solubility, whether in the case of their analytical estimations or in the field of liquid dosage forms in the form of solutions. Commonly used organic solvents for spectrophotometric analysis of water insoluble drugs include methanol, ethanol, chloroform, benzene, dichloromethane, dimethyl formamide, acetonitrile, ethyl acetate, … Read more

Key Point of Dry Powder Injection

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The injectable dry filling area is a completely sterile area of the company that is a strictly controlled area. The high-level alertness is mandatory to main the atmospheric condition in the filling area of the dry powder filling area of Injectable. Every step in the production area requires a written SOP. It is very important … Read more

BATCH MANUFACTURING RECORD OF DRY INJECTION

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BATCH MANUFACTURING RECORD OF DRY INJECTION Table of content 1 Batch Details 2 Attachment 3 General Instructions 4 Calculation of API 5 Dispensing of raw material 6 API transfer record 7 Dispensing of primary packing materials 8 Component preparation for sterilization 9 Steam sterilization record 10 Vial de-boxing, Staging, and Inspection record 11 Vial washing … Read more

Lyophilization of Parenteral

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Lyophilization of Parenteral Lyophilization or freeze-drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes: Freezing Primary drying … Read more

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