ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

Waste treatment procedure for medicinal products which must be utilized/destructed

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Waste treatment  procedure for medicinal products which must be utilized/destructed OBJECTIVE  To provide waste treatment  procedure for medicines which must be utilized/destructed. SCOPE This SOP is applicable to waste treatment compliance of medicines which must be utilized/ destructed. RESPONSIBILITY  Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY  QC … Read more

Physical and chemical quality control test of purified water

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 Physical and chemical quality control test of purified water OBJECTIVE  To provide the procedure of purified water quality control. SCOPE This procedure is applicable to the quality control of purified water in the sampling point. RESPONSIBILITY  Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY  Quality Control and Head … Read more

Refresher training of QC physical-and-chemical laboratory staff

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Refresher training of QC physical-and-chemical laboratory staff OBJECTIVE To provide QC physical-and-chemical laboratory staff with the information about the necessity of refresher training for more effective work. SCOPE  This SOP is applicable to QC physical-and-chemical laboratory staff. RESPONSIBILITY  Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY  QC Head … Read more

Hot plate operation procedure Stuart SD 300

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Hot plate operation procedure Stuart SD 300 OBJECTIVE  To provide the hotplate Stuart SD 300 operation procedure. SCOPE  This SOP is applicable to the hotplate Stuart SD 300 operation procedure. RESPONSIBILITY  Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY  QC Head and QA Head shall be accountable for … Read more

To lay down the procedure of work organization in the microbiological laboratory.

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To lay down the procedure of work organization in the microbiological laboratory. It is applicable to the work organization in the microbiological laboratory. PROCEDURE General items The main task of the microbiological laboratory is to control the microbiological purity production environment and products during all manufacturing levels. The microbiological laboratory does analysis of raw material, … Read more

Maintenance of microbiological control and quality: In stability

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Maintenance of microbiological control and quality: In stability Container-Closure Integrity The ability of the container-closure system to maintain the integrity of its microbial barrier hence, the sterility of a drug product throughout its shelf life, should be demonstrated. Sterility testing at the initial time point is not considered sufficient to demonstrate the microbial integrity of … Read more

Paracetamol and It Mechanisms of action

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Paracetamol and It Mechanisms of action Acetaminophen is an analgesic drug used alone or in combination with opioids for pain management, and as an antipyretic agent. Acetaminophen (paracetamol), is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a … Read more

Ceftriaxone injection

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Ceftriaxone injection CEFTRIAXONE  is a cephalosporin antibiotic and Ceftriaxone injection is used to treat certain infections caused by bacteria such as gonorrhea (a sexually transmitted disease), pelvic inflammatory disease (infection of the female reproductive organs that may cause infertility), meningitis (infection of the membranes that surround the brain and spinal cord), and infections of the … Read more

Fluconazole Tablet

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Fluconazole Tablet Fluconazole is an antifungal medicine that is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, genital area, and the blood. Fluconazole is also used to prevent fungal infection in people who have a weak immune system caused by cancer treatment, … Read more

Manufacture of the finished Dosage Form – QbD: New EMA Guideline

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QbD

Manufacture of the finished Dosage Form – QbD: New EMA Guideline The European Medicines Agency (EMA) published its new guideline on Manufacture of the finished dosage form on August 14, 2017. The guideline replaces the “Note for Guidance on Manufacture of the Finished Dosage Form” (dated April 1996) and will enter into effect on February 14, 2018. … Read more