M .PHARMACY – PHARMACEUTICS
Pharmaceutics is a core technology field in pharma companies and involve manufacturing & evaluation of conventional and innovate dosage forms and utilize equipment such as rotary tablet machine, multi mill, cube mixer, V-blender, dissolution testing apparatus, disintegration apparatus, friabilator, hardness testers, ampul filling and sealing machine, rotary vacuum evaporator, probe sonicator, laminar air flow, high speed homogenizers, etc.
The opportunities include the following:
Pharmaceutical Sector
- Preformulation & Drug Formulation development, production, characterization & packaging of dosage forms
- Design, production, evaluation & scale-up of novel drug delivery systems such as liposomes, solid lipid nanoparticles, dendrimers, Self-nano/micro emulsifying drug delivery systems.
- Controlled drug delivery systems- Transdermal drug delivery systems (including iontophoresis and sonophoresis), Matrix tablets, Gastro-retentive tablets & Microspheres
- Evaluation of developed dosage forms with respect to various in vitro and in vivo parameters
- Biopharmaceutics & pharmacokinetic studies including clinical investigations
- Developing biotechnological and herbal medicines
- Incorporating quality by design (QbD) into Pharmaceutical manufacturing
- Immediate-release dosage forms such as orally disintegrating drug delivery systems
- Enhancement of Dissolution rate of poorly soluble drugs by different techniques, solid dispersions.
- Pharmaceutical method development and validation of various dosage forms
- Accelerated stability studies of various formulations
- Development, characterization and in-vivo evaluation of nanoemulsion gel & in-situ gels
- Development and evaluation of intranasal formulations
- Development and evaluation of ocular formulations
- Industrial Management and GMP Considerations.
- Optimization Techniques & Pilot Plant Scale Up Techniques
- Post approval regulatory requirements for actives and drug products
Information Technology (IT)- Enabled Pharma Sector
- Global regulatory filings such as IND, NDA, ANDA & CTD/eCTD formats
- Chemistry, manufacturing controls (CMC) and their regulatory documentation requirements
- Generic drug Product development
- Clinical trials requirements, Pharmacovigilance and process of quality assurance in clinical trials.
M.PHARMACY- PHARM. ANALYSIS
The Pharmaceutical Analysis is very precious unit of pharmaceutical industry, which involves not only testing but to provide superior quality of end medicinal product, laying emphasis on the quality assurance of pharmaceuticals by utilizing sophisticated analytical instruments such as FTIR, HPLC, LCMS, GCMS, FTIR, UV-Visible spectrophotometers, spectrofluorimeter, flame photometer, sonicators etc.
The opportunities include the following:
- Analytical method development & validation of drugs and various dosage forms
- Bioanalytical method development & validation
- Stability-indicating method development & validation in FR&D
- Degradation studies & Impurity profiling
- Quality Control methods in compliance with various Pharmacopoeias
- Opportunities in Pharma, Phytopharmaceuticals & Food Industries
- Identification, quantification, and purification of a substances in various biological fluids, food and cosmetic products.
- Global regulatory filings such as IND, NDA, ANDA & CTD/eCTD formats
- Best suitable for Women graduates
M.PHARMACY- PHARM. QUALITY ASSURANCE (PQA)
Pharmaceutical quality assurance (PQA) is a high priority, indispensable parts of a pharma company, which includes well- coordinated activities and responsibilities required to ensure that the marketed medicines are effective, safe, acceptable in quality, and at reasonable cost.
PQA has been designed to meet the needs of the ever-increasing demands of the pharmaceutical industry & research organizations with special emphasis on the quality management system and regulatory submissions
PQA includes both technical and managerial activities focused on planning, documenting and agreeing on a set of guidelines that are necessary to assure quality plans, inspection and test plans, the selection of defect tracking tools and the training of people in the selected methods and processes.
QA-QC involves the validation of the quality of drugs and ensuring that the in-process & finished products comply with the standards and guidelines of the regulatory bodies.
The quality control expert is expected to test the accuracy and precision of the company’s products and also document & report the same along with the testing procedures used in the process
The career opportunities in different areas in pharmaceutical industries include the following:
- Quality control and quality assurance which covers the important aspects like cGMP, QC tests, documentation, quality certifications, GLP and regulatory affairs.
- new product development process including expertise on preparation and submission of regulatory dossiers
- Transfer technology from R&D to actual manufacturing
- Quality management principles and systems utilized in the manufacturing industry, including the quality evaluation in the pharmaceutical industries such as quality ISO management systems, tools for quality improvement, Analysis of issues in quality
- Quality evaluation of pharmaceuticals Stability testing of drug substances and formulations
- Analytical and bio-analytical method development and validation, which includes instrumental techniques for identification, characterization and quantification of drugs in single and combination dosage forms
- Post graduates of PQA are also trained and encouraged to build their career as entrepreneurs to start pharmaceutical company or as consultants to pharma companies
