On October 14, 2016, the US Food and Drug Administration (FDA) published a new Guidance regarding Prior Approval Supplements (PAS). FDA says that “this guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs)”. Specifically, …
Read More »FDA: Updated CDER List for 2016 Guidance Documents
On 8 August 2016, the U.S. Food and Drug Administration (FDA) updated the list of new and revised draft guidances CDER is planning to publish until the end of this year. The following documents are listed under the category “Pharmaceutical Quality /Manufacturing Standards (CGMP)”: Data Integrity and Compliance with CGMP …
Read More »SOP on sterilization of garment and surgical hand gloves
Objective To lay down a procedure for sterilization of garments and surgical hand gloves. Scope This SOP is applicable for sterilization of garments and surgical hand gloves. Responsibility Production Officers /Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. LAF : …
Read More »SAMPLING AND ANALYSIS OF WATER/PURE STEAM FOR MICROBIOLOGY LAB
SAMPLING AND ANALYSIS OF WATER/PURE STEAM FOR MICROBIOLOGY LAB PURPOSE: To lay down the procedure for Sampling and analysis of Water/Pure steam for Microbiology Lab. SCOPE: This SOP is applicable to provide the instructions and guidance for Sampling and analysis of Water/Pure steam for Microbiology Lab. RESPONSIBILITY: Microbiologist Person shall …
Read More »SOP on cleaning during media fill trials and decontamination after completion of media fill trials
Objective: To lay down a procedure for cleaning during media fill trial and decontamination after completion of media fill trials. Scope: This SOP describes the procedure for cleaning during media fill trials and decontamination after completion of media fills trials. Responsibility: Production Officers / Executive. Accountability: Production Head shall be …
Read More »Lilly Alzheimer’s Drug Can Save Dismal Year for Pharma
Upcoming results from late-stage data will have major impact on sector By CHARLEY GRANT Updated Nov. 22, 2016 5:06 p.m. ET After a year of drama for the health-care industry, ranging from the EpiPen pricing scandal to the collapse of Valeant Pharmaceuticals International and Theranos to the unknown future of Obamacare …
Read More »SOP for cleaning and sanitization of controlled area
Objective: To lay down a procedure for cleaning and sanitization of controlled area. Scope: This SOP is applicable for cleaning and sanitization of controlled area. Responsibility: Production Officer / Executive. Accountability: Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating Procedure. S.S. : Stainless Steel …
Read More »SOP on Batch preparation of vial filling process.
Objective: To lay down a procedure on Batch Preparation of vial filling process. Scope This SOP is applicable for batch preparation of vial filling process.. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. RM : Raw …
Read More »SOP on operation and cleaning of Pneumatic Lifting Table & Visual Inspection machine
Objective To lay down the procedure of operation and cleaning of Pneumatic Lifting Table & visual Inspection machine. Scope This SOP is applicable for the operation and cleaning of Pneumatic Lifting Table & Visual Inspection used in the vial decartoning room of the sterile Injectable facility. Responsibility Production officer / …
Read More »SOP for cleaning of strapping machine
SOP for cleaning of strapping machineObjective: To lay down a procedure for cleaning of strapping machine. Scope This SOP is applicable for cleaning of Strapping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Procedure The cleaning of Strapping machine is to be …
Read More »SOP for cleaning of BOPP taping machine
Objective To lay down a procedure for cleaning of BOPP taping machine. Scope This SOP is applicable for cleaning of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPA : Isopropyl Alcohol Procedure The cleaning …
Read More »SOP for cleaning of inkjet printing machine
Objective: To lay down a procedure for cleaning of Ink Jet printing machine. Scope This SOP is applicable for the cleaning Ink jet printing machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Cleaning Procedure Press “ON/OFF” switch and wait for two minutes. …
Read More »SOP for cleaning of laminar air flow units.
Objective: To lay down a procedure for cleaning of laminar air flow units. Scope: This SOP is applicable for cleaning of laminar air flow units of Dry Powder Injectable facility. Responsibility Officers or above – Production. Accountability Production Head Shall be responsible for the implementation and compliance of the SOP. …
Read More »SOP for cleaning of vial inspection machine
Objective: To lay down a procedure for cleaning of vial inspection machine. Scope This SOP is applicable for cleaning of vial inspection machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure Procedure Daily cleaning The cleaning is to be done after the days …
Read More »SOP for cleaning of carton coding machine
Objective: To lay down a procedure for cleaning of carton coding machine. Scope This SOP is applicable for cleaning of carton coding machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. IPA : Isopropyl Alcohol Procedure Check that there are no coding stereos …
Read More »SOP for cleaning of vial sealing machine
Objective: To lay down a procedure for cleaning of vial sealing machine. Scope This SOP is applicable on procedure for cleaning of vial sealing machine for Production dry powder Injection facility. Responsibility Production Officers /Executive Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard …
Read More »SOP for cleaning of vial washing machine
Objective: To lay down a procedure for cleaning of vial washing machine. Scope This SOP is applicable for cleaning of vial washing machine. Responsibility Officers – Production. Accountability Production Head. Procedure The cleaning is done after the day’s work is over or whenever necessary. Ensure that the left over vials …
Read More »VALIDATION OF HVAC SYSTEM
VALIDATION OF HVAC SYSTEM INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Sr. No Description Page No. 1 Objective 2 System / Equipment Description 3 Responsibility 4 Execution Team 5 Installation Verification 6 Installation Check 7 Documentation Requirement 8 Deviation Report 9 Installation Qualification Summary …
Read More »SOP for operation of sticker labeling machine
Objective: To lay down a procedure for operation of labeling machine of pharmaceutical company. Scope: This SOP is applicable for sticker labeling machine. Responsibility: Production operator / Technician – responsible for operation of machine. Production officer / Executive – to ensure that operation of the machine is carried out as …
Read More »SOP for cleaning of vial labeling machine
Objective: To lay down a procedure for cleaning of vial labeling machine. Scope This SOP is applicable for the cleaning of vial labeling machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Cleaning Procedure At the end of the shift /batch change over …
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