Pharamaceutical&LifeSciences

Traing in Pharama Industry: 1.Hr Traing(Induction Training). 2.Safety Traing(Safety Precatution). 3.Quality Assurance(QA rules). 4.Use Department(Work process intial and implement). 5.Ware House(raw material msds). 6.Engineering Service(Proceding interaction b/w inter department). 7.Qulality Control(about sampleing information interaction). 8.Research Development(deviation in Process). Fresher required 30 days training required,Experienced below jr manager 15 days training required,above jr manager and below gm training 7 days. Gm required self training required on that date he got sign. Employee have Casual leaves,Earned leaves,Sick leaves,PH,Weak Off.

  Sop Page Format in Pharama : Sop page contain Header space 1.4",Footer space 1.3",Page right hand side space 1.4" and Left hand side space 1.3".and Headings and Subheadings, Body content. Header of sop format first right hand side top write company logo and Middle top Company Name ,Top left side page no. Header second row sop no next version no next version no next effectivedate, Sign and date. Header third row Title of Sop no . Heading and subheading in body with page it bold letters of  Times New Roman .the font size should be 14. Body contain Numerical sequence no and it contain with out bold letters and the font size  should be 12. The font paragraph contain line space 1.5 ". Footer section space should be 1.3" . It contain Responsibilties ,departments,Sign and Date these colums contain prepared by , checked by , Approved by.these all letters should be times new roman it font contain 14.

  Some Importent Points of Pharama Industry: Note down points verification process  men Machine/equipment/instrument/day tank Material Method Development Process Method of Analysis Utilities these all observed batch fail time.  Swan--- soil water air nature. Permits to work: Form's User department check list Engineering Services Check list Safety Recomended Plant Head Work Cleareance close with in 90 days

  Plant Pharama industry improtent Things: Customer /Regulator/Statury FDA/USFDA/External Audit/Internal Audit/EUP/ISO/WHO/Drug Inspection/Factory Inspection/Polloution Control Board/Vendor Qualification/21 CFR/Pollution Control Board etc these type of Audits in pharam Industry. Every Pharama Company Follows these things   Policies,Quality,&Environmental  Health&Safety. Products prepared in Bulk drugs. Documents. BPR,SOP'S ,STP'S ,MSDS ,ANEXUOR'S,FORMS,COA'S,SPEC'S. EQUIPMENT/INSTRUMENT/UTILITIES. DESIGN QULIFICATION,INSTALATION QULIFICATION,OPERATIONAL QUALIFICATION, PERFORMANCE QUALIFICATION/CALIBRATION VALIDATION. FACILITIES. LAYOUTS. PHYSICAL & VISUAL. PAINTING/ARTIST/LABELS/STATUS  BOARD/CHANGE CONTROL /DEVIATION ETC,.

  Validation In Pharam Industry: Validation is the execute the process predefined protocal execute the match the predefined requirement. Process Design. Contineous Process Verification. Performenance Qualification. Process Validation : Critical Process Parameter,How many batches, Impurities,Quility and Yield as per the predefined requirement. Prospective Validation. Retrospective Validation. Concurrent Validation.

Importent Points in Pharama Industry: Handling specification  impurities Trial Batch(RD & A R&D) Critical Process Parameter In Process R&D ,A R&D  small scale batches Design Qualification Area(Plant) Process Validation : Critical Parameter,How Many Batches, Impurities,Yield,Quality. Validation Protocol: Critical Process Parameter,Specification ,Yield,Quality, Equipment, Revolidation: Process Major Changes ,Equipment Changes,Raw Material Changes. Design Qulification, Installation Qualification,Operational Qualification,Performance Qualification Before three batch execution of manufactureing based on Customer. \