Production

Sanitizing the clean rooms  PURPOSE: To lay down the procedure for sanitizing the clean rooms in normal operation and during various interruptions to make the clean area free from microbial & particle load. RESPONSIBILITY: Concern Department Person For the preparation of the Sanitization Solution. Production  Person To ensure the sanitization process. …

Working Principle of Auto Coater Machine The film to be coated on the tablet is in liquid form before the process is started so the liquid is filled in the solution tank. The liquid is stirred well in the solution tank and then pumped into the coating pan. The coating …

Reprocessing of non-confirming products (Formulation) To establish a procedure for Reprocessing non-confirming products (formulation). SCOPE: This SOP is applicable to all sections of the formulation. RESPONSIBILITY: Department in charge – Implementation of SOP & Documentation. Quality Assurance Person – To verify & monitor the activities as per SOP. R&D Person – Clearance from R&D …

Autonomous Disinfection Solution there is a new technological solution that has emerged in recent years to help combat the spread of disease in public spaces: autonomous disinfection robots. These robots are capable of cleaning and disinfecting public areas without human intervention, making them an ideal solution for high-traffic areas where …

Pseudoephedrine & Mechanism of Action Pseudoephedrine temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, and nasal congestion associated with sinusitis. Pseudoephedrine also temporarily relieves sinus congestion and pressure. Drug Class: Nasal Decongestant MECHANISM OF ACTION Pseudoephedrine is a sympathomimetic drug belonging to the phenethylamine and amphetamine chemical classes. Its principal mechanism of …

Hydrochlorothiazide and its Mechanism of Action Hydrochlorothiazide is a thiazide diuretic used to treat edema associated with a number of conditions, and hypertension. Hydrochlorothiazide is the most commonly prescribed thiazide diuretic. The drug has been widely used to treat hypertension globally and is relatively very safe. Hydrochlorothiazide acts on the …

Liquid pharmaceutical Preparations A solution is a homogenous one-phase system consisting of two or more components. →solvent + solute • The solvent is that phase in which the dispersion occurs and the solute is that component that is dispersed as small molecules or ions in the solvent. • Liquid preparations: …

PARENTERAL PREPARATIONS Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body. Parenteral preparations may require the use of excipients, for example, to make the preparation isotonic with respect to blood, to adjust the pH, to increase solubility, to prevent deterioration …

Most common types of pharmaceutical contamination Contamination can lead to objectionable results in the Pharma industry. It can conciliate the safety of patients, staff, and the environment – as well as affect the market. High standards of hygiene are important to maintain, only preventing the bio-burden levels by means of …

Isolators In Pharma Industry Isolators are clean air devices providing complete separation between an aseptic process (hazardous/non-hazardous), the technical personnel, and the surrounding work environment. Isolators are generally used in applications requiring a high degree of protection from external elements or contaminants, and they can serve as alternatives to sophisticated …

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules A. Differences in Size and Shape of Tablets and Capsules between a Reference Listed Drug and a Drug Product Subject to an Abbreviated New Drug Application 1. Size Difficulty swallowing tablets and capsules can be a problem for many …

Continued Process Verification As Per WHO TRS1019 Annex 3 Manufacturers should monitor the product quality of commercial batches after completion of process design and process qualification. This will provide evidence that a state of control is maintained throughout the product life cycle. The scope and extent of process verification will …

Quality Metrics in pharmaceutical industry Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. Quality Metrics play an important role in the desired state of pharmaceutical quality and regulation – minimal but effective regulatory oversight that …

Bung Processor / Autoclave Definition of Autoclave An autoclave is a pressure chamber used to carry out industrial processes requiring elevated temperature and pressure different to ambient air pressure. Autoclave is used in medical application to perform sterilization, and in the chemical industry to cure coatings, vulcanise rubber and for …

VIAL WASHING MACHINE An automatic rotary vial washing machine with an integral washing tank for recycled water, with multiple washing stations, is designed to clean the glass vials internally and externally with different washing media in six stages at the rated output of 120 vials per minute. Operation by the …

Sterilization and depyrogenation tunnel        

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 …

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 …

Batch Manufacturing Record(BMR) Product Name: Atorvastatin  calcium equivalent to Atorvastatin 10 mg,Batch Size:2000000 tablets Composition Each film-coated tablet contains: Atorvastatin  calcium equivalent to Atorvastatin 10 mg Checklist of BMR Check Points Batch release and composition Checklist of BMR General instruction Line clearance check for  dispensing Dispensing sheet of Raw Material …

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 …