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Required Drug Substance (Viral Vaccine Experience)- Upstream /Downstream Processing of viral vaccines

Job Opportunity - Drug Substance (Viral Vaccine Experience) Bharat Biotech is looking for skilled professionals with hands-on experience in Drug Substance manufacturing for Viral Vaccines. Details are provided below  1. Location: Hyderabad 2. Experience: 2-6 Years 3. Key Skills & Experience Required a. Experience in Upstream /Downstream Processing of viral vaccines b. Operation and handling of bioreactors, fermenters, centrifuges, chromatography systems, filtration units c.  Knowledge of cell culture techniques (mammalian/avian cell lines)  d. Familiarity with aseptic techniques, GMP documentation, batch records e. Understanding of process optimization, scale-up, and technology transfer f. Exposure to in-process testing, troubleshooting, and equipment cleaning/sterilization g. Ability to work in a regulated, fast-paced manufacturing environment 4. How to Apply Interested candidates can share their updated CV to kiran4978@bharatbiotech.com Mention subject line as: Appl...
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USP (United States Pharmacopia) Chapters and Guidelines


 

Hello dear students , job seekers if you are dreaming to do job in pharmaceutical industry the knowledge of different techniques of microbiology used in pharmaceutical industry is very important. In this article I am giving the list of USP chapters and the guidelines of particular tests given in that chapters.

       Hope this article will be helpful to you !!

Kindly share with you friends !!!!

Source- Food and Drug Administration - Pharmaceutical Microbiology Manual 

a. USP  <1>   Injections

b. USP  <51> Antimicrobial Effectiveness Test

c.  USP <55> Biological Indicators- Resistance Performance Tests.

d. USP <60> Microbiological Examination of Non sterile Products : Tests for Burkholderia capacia complex.

e. USP<61>  Microbiological Examination of Non sterile products : Microbial enumeration Tests

f. USP<62> Microbiological Examination of Non sterile products :Tests for specified microorganisms.

g. USP<63> Mycoplasma

h. USP<71>Sterility Tests

i. USP<81>Antibiotics- Microbial Assays

j. USP<85>Bacterial Endotoxin Test.

k. USP<151>Pyrogen Test.

l. USP<161>Transfusion and infusion Assemblies and similar medical devices.

m. USP<171>Vitamin B12 Activities Assay

n. USP<797>Pharmaceutical Compounding- Sterile Preparations.

                        *** Informational Chapters***

a. USP<1035>Biological Indicators For Sterilization.

b. USP<1072>Disinfectants and Antiseptics.

c. USP<1111>Microbiological Examination of Non sterile products : Acceptable Criteria for pharmaceutical Preparations and Substances for Pharmaceutical use.

d. USP<1112>Application of Water activity determination to Non sterile pharmaceutical products.

e. USP<1113>Microbial characterization, identification, and strain typing.

f. USP<1116>Microbiological evaluation of clean rooms and other controlled environments.

g. USP<1117>Microbiological Best Laboratory Practices.

h. USP<1207>Sterile Products Packaging- Integrity Evaluation.

i. USP<1208>Sterility Testing- Validation of Isolator Systems.

j. USP<1209>Sterilization-Chemical and Physicochemical Indicators and Integrators.

k. USP<1211>Sterilization and Sterility Assurance of Compendial Articles.

l. USP<1223>Validation of  alternative microbiological methods.

m. USP<1227>Validation of Microbial Recovery from Pharmacopeial Articles.

n. USP<1237>Virology Tests Methods.

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