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 …

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 …

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, …

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 …

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 …

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 …

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 …

1.Question: Definition of Good Manufacturing Practices (GMP) as per WHO ? Answer: WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.” GMP covers …

Process Validation The concept of the product lifecycle connects the development of the product and the manufacturing process, the qualification of the commercial manufacturing process, and the maintenance of the process to ensure control during routine production. This guidance promotes scientific principles to support process improvement and innovation. This guidance …

Purified Water Purified water is more than just a thirst-quenching beverage; it’s a cornerstone of health and well-being. In this blog, we explore the significance of purified water, the various purification methods, and why its consumption is essential for a healthy lifestyle. Purification Methods: Purified water undergoes processes that eliminate …

STABILITY STUDY MANAGEMENT To lay down the procedure to conduct stability studies of the drug product (dosage forms)/ Drug substances (API). This Document describes the procedure for assigning the stability of drug substances (Active pharma ingredients) and drug products (Packed finished dosage forms). The purpose of stability studies is to …

Cleaning Validation Protocol CONTENTS S. No. Topic Page No. 1.0 Protocol Preparation and Approval Sheet 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Validation Team 6.0 Abbreviations and Definitions 7.0 Cleaning Validation Approach 7.1 Selection of Products 7.2 Selection of Equipments 7.3 Type  Cleaning after every five consecutive batches of the …

Hydro Testing Procedure for Purified Water Distribution Loop Objective : To ensure that the Purified Water Distribution Piping is Leakage proof from TC joints & Orbital Weld joints. Scope :Applicable for Hydro Testing of Purified Water Distribution Loop Procedure : Fill the Purified Water Distribution piping loop completely with Purified …

Objective : To ensure that the Purified Water Distribution System is Chemically cleaned. Scope :Applicable for Passivation and Cleaning of Purified Water Distribution Loop Procedure : Fill the Purified Water Storage Tank till the Half Level.  Ensure Suction & Discharge valve of pump are open and all user points & sampling …

Objective : To take the photographs of pipe weld joints made by fusion of base material without the addition of filler and recorded in the attached compact disc and should meeting the required specifications mentioned below.  Uniformity in weld joint. Should have proper penetration. Should not have any foreign object …

Orbital Welding Procedure for purified water system Objective : To get more consistent root weld beads and weld overrun, pinholes should be absent. Scope :This SOP is applicable for Orbital Welding of purified water system Procedure : Ensure the welder is qualified before starting of welding. Clamp the welding head at …

Hot Water Sanitization Procedure of Purified Water Distribution Loop Objective : To ensure that the Purified Water Distribution Loop along with the tank is sanitized at 85 degree Centigrade to reduce the microbial count. Scope : Procedure : Fill the Purified Water Storage Tank till the Half Level. Ensure Suction …

Dead Leg for Purified Water Storage & Distribution System A dead leg within a water distribution system denotes a segment of piping that is no longer actively utilized. It has the potential to foster microbial contamination, thereby posing a risk to the overall quality of the water. Dead legs may …

Current Good Manufacturing Practices in Pharmaceutical Industry The cGMP requirements are described in the various guidelines which deal mainly in the following categories, e.g., (A) Requirements related to surroundings. (B) General requirements for pharmaceutical plants. (C) Requirements related to various departmental areas in the plant and (D) Requirements related to …