BUA is an in-process test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product. Definition Blend Uniformity (in accordance with FDA Guidance for Industry, ANDAs: Blend Uniformity Analysis, 1999) In-Process Control Scope BUA or homogeneity testing can be applied to all dosage … Read more
Objective: To lay down a procedure on assembly of cartridge filter in housing. Scope This SOP is applicable for assembly of cartridge filter in housing. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. WFI : Water For Injection Procedure Close the valve of compressed air or Nitrogen Line … Read more
Objective: To lay down a procedure for collection and disposal of waste & rejected material from plant. Scope: This SOP is applicable for collection and disposal of waste & rejected material from plant. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. S.S. : Stainless Steel WFI : Water … Read more
SOP On Document and Data Control Objective: To lay down a procedure for control of documents and documented data. Scope: This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible to follow this SOP for … Read more
Objective: To lay down a procedure on operation and cleaning of sterile garment cubicle. Scope This SOP is applicable for the operation and cleaning of sterile garment cubicle. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. LAF : Laminar air flow U.V. : Ultra violet Procedure Operation: Sterile … Read more
Tips for Getting Your Stress under Control for Good Stress at work warning signs When you feel overwhelmed at work, you lose confidence and may become angry, irritable, or withdrawn. Other signs and symptoms of excessive stress at work include: 1. Feeling anxious, irritable, or depressed 2. Apathy, loss of interest in work 3. Problems … Read more
Objective: To lay down a procedure for final packing of products Scope This SOP is applicable for final packing of products for Production dry powder Injection facility. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Poly Propylene. MFG. : Manufacturing EXP. : Expiry Procedure … Read more
Objective: To lay down a procedure for cleaning and sanitization of goggles used in aseptic area. Scope This SOP is applicable for procedure of cleaning and sanitization of goggles used in aseptic area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. … Read more
Source :GMP News 16/11/2016 During its inspections, the FDA has been observing insufficient data integrity quite often in the Far East. Now, European production sites are not always exemplary. A Warning Letter recently published for the Czech Company Interpharm Praha describes considerable deficiencies in the area of quality control with regard to API and finished products … Read more
Source : GMP News 09/11/2016 Chapter 5 of the EC GMP Guide for the area of production was already updated last year. However, not everybody really knows that it contains concrete information about the conditions when testing and sampling of APIs and excipients can be reduced. Particularly sections 5.35 and 5.36 include requirements and thus show possibilities … Read more
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, the guidance describes how the … Read more
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 Expiration Dating of Unit-Dose Repackaged … Read more
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 : Laminar Air Flow Procedure Controlled … Read more
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 be responsible for: To follow … Read more
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 accountable for the compliance of … Read more
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 to a series of mergers, … Read more
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 Procedure: Following are the areas … Read more
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 Material PM : Packing material … Read more
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 / Executive. Accountability Production Head shall … Read more
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 done after day’s production is … Read more
