Drug stability in Pharmaceutical products

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 while formal stability studies establish … 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 and requiring no rinsing or … 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 smooth, easily cleanable surfaces and … 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 210 and 211). All sections … 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 – can be used to … 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 method or air sampling at … 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 Pharmacovigilance Plan into the Common … 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 the water purification process. RESPONSIBILITY … 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: START UP Inspect the following … 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 stage of operation prior to … 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 Stearate 0.75 Croscarmellose Sodium 3.00 … 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 bags with polybag inside Packed … 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 was established in 1947 as … 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 / Hold / Rejected / … 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 / Hold / Rejected / Not … 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 / Hold / Rejected / Not … 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 / Rejected / Not Applicable] … 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 / Hold / Rejected / … 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 Years  1.21 Lacs BA in … 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 documents, labels, materials or any … Read more