dr. a. amsavel amsavel gmp deviation calibration instrumentation instrumentation and application in pharmaceutical theory principle stationary phase qualification recall capa complaint investigation report oos analytical chemistry qc dr.a. amsavel apqr emergency approval ethical committee formulation & dosage faers invitro invivo target hts post marketing data nda and fda approval clinical trial preclinical research discovery & development drug discovery path compliance confidence improvement measurement batch acceptance rate stability oos rate invalid oos rate apr completion rate complaint rate cder quality metric molecule arrangements in solids preparation of ploymorphs ssnmr spectrophotometry in the infrared region ft-ir & raman optical crystallography thermogravimetry (tga) differential scanning calorimetry(dsc) xrpd pseudopolymorphism polymorphism polymorph optical isomer ee enantiomeric excess chiral factors affect the optical rotation polarimeter optical rotation specific optical rotation isomers and enantiomers column chemistry instrumentation & types of detectors glc sec gpc ionexchange reversed phase normal phase hplc techniques chromatographic separation application hplc high performance liquid chromatography personal hygiene guideline protective clothing & gowning procedures & records health examination training & practice hand wash source of contamination and control personal hygiene metastasis: mutation genetic problem types of cancer treatments stages of cancers (tsm) palliative care radiation therapy chemotherapy classification of cancers awareness on cancer ftir spectroscopy pharmaceutical analysis stray light molar absorption coefficient molar absortivity control of absorbance control of wavelength factors influence the absorption chromophores & auxochrome beer- lambert law molecular absorption theory uv &visible spectroscopy pharma industry. pharmacopiea sample injection packed column capillary column detector corbowax polydimethylsiloxane chemical phase carrier gas column injector gc instrument definition application. chromatography theory instrumentation gas chromatography- principle ichq7 sop crm usprs ph.eur crs working standard potency secondary standard reference standard ahu hvac air sampling settle plate sources of contamination iso14644 disinfectant bioburden cleaning of clean rooms equipment environment monitoring air classification hepa cleanrooms contamination control requalification and revalidation dmf annual update adverse stability trend reprocess and rework return goods change control apr pqr response to customer far trend mrm effectiveness of capa containment remedial action 21 cfr § 211.198 and ich q7 sop for complaint handling investigation documents & records destruction annual verification access storage quantity of sample for packing packing of sample sample withdrawn for testing of complaint guideline requirement handling of reserve samples meta data raw data gxp glp data integrity qualification for reviewer role of reviewer reagent record sample record calibration record audit trail chromatograms lab control records purity strength quality rounding up rules description & solubility fda api reagents & solutions frequently used gcs. universal tests storage conditions packaging and storage general notices general chapters monograph usp investigation steps investigation process investigation tools deviation reporting human error verification of capa effectiveness kt fta cause&effect fishbone 5why root cause rca oos & complaint investigation and capa batch rejection /disposition conclusion on oos minimising oos citation on oos oos trend barr lab vs fda oot lab investigation volumetric analysis volumetric analysis- dr. a. amsavel analytical method validation basic good laboratory practices by dr. a. amsavel pharma industry data integrity training by dr. a. amsavel weighing balances pharma qc gcp by dr. a. amsavel principles of nat & uses in qc lab- dr.a.amsavel bpr review batch release lab safety- dr. a. amsavel gmp-vmp dr.amsavel pharma job process validation gmp-deviation handling
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