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

Cephalosporins Drugs

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Cephalosporins Drugs Cephalosporins are beta-lactam antimicrobials used to manage a wide range of infections from gram-positive and gram-negative bacteria. The five generations of cephalosporins are useful against skin infection, resistant bacteria, meningitis, and other infections. This activity describes the indications, contraindication, and possible adverse effects of cephalosporins and will highlight the mechanism of action, adverse … Read more

SOP for QMS Tools

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SOP for QMS Tools Document Management –Review batch records, stability reports, validation reports, and associated documents required to comply with respective regulatory country GMP. Site Deviations – initiation, investigation, review, closeout, and maintenance for internal and external issues. Change Controls – initiation, review, closeout, and maintenance of all internal and external change controls. CAPA Management – manages … Read more

VALIDATION OF FREEZE DRYER

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VALIDATION OF FREEZE DRYER “In freeze-drying, water is removed from the frozen state by sublimation, i.e., direct change of water from solid into vapor without conversion to a liquid phase”. Used for drying of a no. of products. Especially, Blood plasma and its fractionated products. Bacterial and viral cultures. Human tissues. Antibiotics and plant extracts. … Read more

Job pharma WhatsApp group link

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Job pharma WhatsApp group link Pharma Jobs (90) https://chat.whatsapp.com/Fw14tT8ThZF0pV0pMGDVZ9 Pharma Jobs Hub 04 (116) https://chat.whatsapp.com/Fc0f8DpBucQ5jc7ltXe1Uy Pharma Jobs Hub 03 (82) https://chat.whatsapp.com/HohCLKKqLU34chFxjg2GGW Pharma Jobs Hub 02 (93) https://chat.whatsapp.com/DaH99Qu1Ato9NmBx4tzVo5 Pharma Jobs and Post (219) https://chat.whatsapp.com/Dy1GkgHZloYJPsfzIC6tnZ Pharma Jobs and Post 02 (196) https://chat.whatsapp.com/La8yGcVqeknKkfEeymYwMv Pharma Jobs and Post 03 (157) https://chat.whatsapp.com/CLI4oqKyVAf9nKNbbOz1Hc Pharma Jobs and Post04 (75) https://chat.whatsapp.com/FcWSnKoKm7BB7S8AXOyR3i Pharma Jobs … Read more

Retesting of  Primary Packing Material (PPM)

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Retesting of  Primary Packing Material (PPM) Objective: To lay down the procedure for retesting of primary packaging material (PPM). Scope:  This SOP is applicable for retesting of primary packaging material in Quality control Responsibility:  Chemist or above of QC Department for retesting of PPM.  Officer or above of Warehouse Department for giving request for retesting … Read more

SOP on Intermediate and finished product Analysis and Approval

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SOP on Intermediate and finished product  Analysis and Approval To lay down the procedure for testing Intermediate samples and finished product. Procedure: Quality Assurance personnel shall collect the sample of finished and intermediate products and affix the “sample for analysis” label along with a Sample Intimation Slip filled with all details. The finished product shall … Read more

SOP on handling of rinse and swab sample

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SOP on handling of rinse and swab sample Objective: To lay down the procedure for handling of rinse and swab sample. Scope: This procedure is applicable for handling of rinse and swab sample in QC Department Responsibility: Chemist or above of QC department Executive / nominee of QC department Accountability: Head – Quality Control department … Read more

SOP on handling of alarm system of Stability Chambers

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SOP on handling of alarm system of Stability Chambers Objective: To lay down a procedure for alarm system of stability chambers. Scope: This SOP is applicable to handling of alarm system of stability chambers Responsibility: Chemist or above of QC Laboratory Electrician or above of Engineering department Security supervisor or above Accountability: Head – Quality … Read more

SOP on cleaning, maintenance and calibration of Cooling cabinet

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SOP on cleaning, maintenance and calibration of Cooling cabinet Objective: To lay down a procedure for Cleaning, maintenance and calibration of Cooling cabinet. Scope: This SOP is applicable for the cleaning, maintenance and calibration of cooling cabinet Responsibility: QC Chemist or above Electrician or above Accountability: Head – Quality Control Head – Engineering Procedure: Cleaning : … Read more

SOP on Operation of Cooling cabinet

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SOP on Operation of Cooling cabinet Objective: To lay down a procedure for the operation of Cooling cabinet. Scope: This SOP is applicable to quality control laboratory Responsibility: Chemist or above of QC Laboratory. Electrician or above of Engineering. Accountability: Head – Quality Control. Head – Engineering Procedure: Following points shall be checked before starting … Read more