Drug stability in Pharmaceutical products Pharmaceutical products are assigned a shelf life which determines the time when a product is considered to be safe and effective under storage conditions. Stability studies should be based on pharmaceutical R&D and regulatory requirements. Degradation studies reveal the intrinsic chemical properties of the API …
Read More »General Terminology used for good Hand hygiene practices as per USFDA
General Terminology used for good Hand hygiene practices as per USFDA Hand hygiene practices Antiseptic handwashing Washing hands with soap and water,or other detergents containing an antiseptic agent. Antiseptic handrubbing (or handrubbing). Applying an antiseptic handrub to reduce or inhibit the growth of microorganisms without the need for an exogenous source of water …
Read More »Good Manufacturing Practice (GMP) Inspection Checklist as per USFDA
Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist Building and Facilities. Check whether Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance. Floors, walls and ceilings are constructed of …
Read More »COMPRESSED MEDICAL GASES AS PER USFDA GUIDELINE
COMPRESSED MEDICAL GASES AS PER USFDA GUIDELINE INTRODUCTION This guideline describes practices and procedures for compressed medical gas (CMG) fillers (including companies engaged in home respiratory services) that constitute acceptable means of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug products (21 CFR Parts …
Read More »Data Integrity In Pharmaceuticals
Data Integrity In Pharmaceuticals Data integrity: Data integrity is a fundamental component of information security. In its broadest use, “data integrity” refers to the accuracy, reliability and consistency of data stored over its entire life-cycle in a database, data warehouse, data mart or other construct. The term – Data Integrity …
Read More »PROCEDURE FOR VIABLE AIR MONITORING
PROCEDURE FOR VIABLE AIR MONITORING OBJECTIVE:To lay down a procedure for environmental monitoring of air. SCOPE:This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY :Quality Control Executive / Officer. ACCOUNTABILITY:Head Quality Assurance. PROCEDURE:The microbial environmental conditions of unit II shall be monitored by Settle plate …
Read More »PHARMACOVIGILANCE PLAN AS PER ICH
PHARMACOVIGILANCE PLAN AS PER ICH Pharmacovigilance plan especially in preparation for the early postmarketing period of a new drug . Pharmacovigilance Plan that might be submitted at the time of licence application. Pharmacovigilance plan can be used by sponsors to develop a stand-alone document for regions that prefer this approach …
Read More »PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER
PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER OBJECTIVE:To lay down a procedure for microbiological monitoring of raw water and purified water. SCOPE:This SOP shall provide the procedure for sampling and testing of raw water and purified water from all the user points and all the points across the critical functions in …
Read More »IN-PROCESS CONTROL OF PACKING LINE of TABLETS
IN-PROCESS CONTROL OF PACKING LINE of TABLETS OBJECTIVE: To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE: This SOP shall be applicable in-process controls during strip packing and final packing operation of tablets. RESPONSIBILITY: In process Quality Assurance Officer / Executive. ACCOUNTABILITY: Head Quality Assurance PROCEDURE: …
Read More »INPROCESS CONTROL DURING TABLET MANUFACTURING
INPROCESS CONTROL DURING TABLET MANUFACTURING OBJECTIVE: To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE: This SOP shall be applicable for in process controls during tablets manufacturing. RESPONSIBILITY: In process Quality Assurance Executive/Officer. ACCOUNTABILITY: Head Quality Assurance. PROCEDURE: Carry out line clearance at each …
Read More »Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets
Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets Bill of Material Ingredient Quantity in kg Dextromethorphan Hydrobromide and Chlorphenamine Maleate complex 12.12*# Phenylephrine Hydrochloride complex 8.08**# Mannitol (Pearlitol SD200, Roquette) 42.80 Silica, Colloidal Anhydrous 2.00 Indion 294 3.00 Talc 0.50 Magnesium …
Read More »RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST
RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST Material Name: AR No./MRR No./ Date: SNo. Description Check Point 1 Environmental Conditions Temperature RH 2 Under test label Affixed / Not affixed 3 Packing Packed in carboys / drums Packed in fiber/plastic drums with polybag inside Packed in PP woven …
Read More »International Organization for Standardization
International Organization for Standardization ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies.Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. The ISO is a multinational agency . It …
Read More »LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING Dosage Form: Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time PACKING [Released / Not Released …
Read More »LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE Dosage Form: Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time INSPECTION [Released / Not Released / …
Read More »LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time COATING [Released / Not Released / …
Read More »LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COMPRESSION
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COMPRESSION Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas /Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time COMPRESSION [Released / Not Released / Hold …
Read More »LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time BLENDING [Released / Not Released …
Read More »Education in Ukraine offers Courses & Fees
Education in Ukraine offers Courses & Fees Sumy State University (SSU), Sumy Courses & Fees B.Tech. (Bachelor of Technology) Available Courses Course Name Duration Fees(Annual) BA in Mechanical engineering 4.0 Years 1.21 Lacs BA in Heat and power engineering 4.0 Years 1.21 Lacs BA in Engineering Materials Science 4.0 …
Read More »LINE CLEARANCE CHECKLIST FOR DISPENSING BOOTH
LINE CLEARANCE CHECKLIST FOR DISPENSING BOOTH Dosage Form: Date / Time: Product: Batch No. : Previous Product: Batch No. : Dispensing Booth No.: Sr. No. Check points Observations Done By Checked by Verified By QA Active Excipient Colour Production Warehouse Room Identification number: 1 Ensure the absence of batch …
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