Pharamaceutical&LifeSciences

  Safety Equipment in Pharama Industry: Fire Hydrent line in whole plant. Mobile Foam tralley. Different types of fire extinguishers like. liquid foam type fire extinguisher. powder type fire extinguisher-Dry chemical powder fire extinguisher gas type fire extinguisher-co2 fire extinguisher nitrogen blanketing Safety things used in pharam according to the situvation  hand gloves,goggles,helmet,head cap,air suite,ofron,faceshield,dongrey,shoes,lader,safety belt

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. \

  Permits Types in Pharama Industry: General Permit: bulb,bolt line etc. Hot Permit: Spark created when communicate to the Enurment. Height Permit: Production remover material some distences production. Lader,Safety belt,helmet, gloves engineering Serivices. Vessel Entry/Confined Space Entry. Power Isolate:Remove parts safe loser limit time 10 min. Heavy equipment Movement installation /dismatching /movement. crain,chain. Excavation(diging, remove sparking). Loading and Unloading (ware house). Security Check(store -30 stop permit Sample). Electrical :Electrical power removeing and connecting the after required. APQR: Annual Product Quality Review. Pipe Line Joints open (civil steam,water flush out). CF work permit. Dryer Operation Permit. Hot/vessel/Electrical  these types work permits in there production area.

  Cleaning Validation: Not more than 10ppm. Batch to Batch cleaning . Periodical cleaning. Product Change Over Cleaning. DEHT: dirty eqipment holding time 24 hrs intermediate. CEHT:cleaning eqipment holding time . Document evidence clean rooms 15 days. Contamination same product to mix another product called cross contamination.

  Procedure for Filling of Batch Preparation Record: Manufacturing personnel hand over the completed BPR to quality assurance department  with in 48 hours from the date of Batch Approval. Sample Label. Technical Inforamation Sheet. Analytical Test Requestion. Quarantine Label. Sampleing and Sealing Record. Dispensing Label.

  Avoding Cross Contamination  During Batch Charging:       Ensure  the cleanliness of the reactor and its surroundings visually .       Weigh /Measure  and bring the required quantity of raw material near to the      reactor as per BPR. During charging of solid  material into the reactor ensure that the manhole  of adjacent /oppsite reactor should be in closed condition. Remove the raw material containers and polyethylene bags after charging of  the raw material into the reactor.

  Procedure for Checking of Dispensing  Labels: Dispensing and Issuance label are filled and signed with required information and affixed to the containers/drums before charging. Partial dispensing then the Materal Distribution Record.

Discarding Material in clean room:   Executive / Head of store (RM) shall be responsible for implementation of the procedure. Respective Heads of Quality Assurance, Quality Control, Pharma Research, Store (RM) and Materials Management shall be responsible for destruction of expired / obsolete material(s) (and if required, with requirements of other pharmacopoeias) in their area. In case of Imported Raw Materials, Head Export will raise a request note to DRA for finalization of expired or obsolete material(s) after correspondence & authorization of destruction with the Drug Controller General (India) / Deputy Drug Controller or Drug Controller Authorities. Director, operation & projects shall be responsible for authorization of destruction of expired / obsolete Raw Material(s). Abbreviations and Definitions RM                    :        Raw Mater...

  Area Cleaning Operation in Clean Room In Production pharama Industry: Start cleaning of the area after the cleaning of the equipments. Start the cleaning operation of ceiling and then to walls from top progressing to downwards. Clean the door and window glasses using (Disinfectant solution) wet duster. Clean the doors, door closures, handles and all the hinges of the door using dry followed by wet and again with dry duster. If weighing balance is present in the processing room, clean it by using wet duster followed by dry duster. Clean the pallets, trolleys, etc using a wet duster followed by a clean dry duster.   Remove the dust from the switchboards, utility pendants using the vacuum cleaner and wipe with clean dry duster. Clean the SOP stand using clean dry duster.   Clean the accessories box using the wet duster followed by clean dry duster.   Clean the ceilings of Air Handling Unit (AHU) supply grilles with a pipe brush and vacuum cleaner during a product chan...

  Who Guidelines in Pharama  Industry: World health organization (WHO)   provides the GMP guidelines for pharmaceuticals. These guidelines are followed through out the world. These guidelines cover all the pharmaceutical topics as. Quality management in the medicines  industry, philosophy and essential elements  harmaceutical  quality system   Quality risk management   Product quality review  Good manufacturing practices for  pharmaceutical  products  Sanitation and hygiene   Qualification and validation  Complaints  Product recalls .  health organization (WHO)  provides the GMP guidelines for pharmaceuticals.  These guidelines are followed through out the world.  These guidelines cover all the pharmaceutical topics as: Process validation,  Cleaning validation, Analytical method validation ,DQ, IQ, OQ, PQ of equipment;  Water system validation;  HVAC validation;...

  21 cfr part 11 guidelines: SUBPART A – GENERAL PROVISIONS Scope Implementation Definitions SUBPART B – ELECTRONIC RECORDS   Controls for closed systems   Controls for open systems  Signature manifestations  Signature/record linking  SUBPART C – ELECTRONIC SIGNATURES    General requirements  Electronic signature components   and controls Controls for identification   codes/passwords

  SOP on Calibration of Weighing Balance : Purpose: To lay down the procedure for the calibration of weighing balances. Scope: Applicable to all weighing balances except analytical balances. Responsibility: Department Head. Definitions: Calibration: The set of the operations which establish under specified conditions , the relationship. Procedure. Preparations before calibration. Before you can start the calibration of the weighing instrument, you . Eccentricity test. In normal use of a weighing instrument, the load is not always placed perfectly on . Repeatability test. As any instrument, also weighing instruments may suffer from repeatability . Weighing test. The purpose of the weighing test is to test the accuracy (calibrate) of the weighing . The check should be made before the first  weighing  of the day or after any event that might disturb the  balance's calibration  (power failure, moving the  balance  to a new location, etc.). The check- weig...

  Gmp and Cgmp diffeerence between: Definition. GMP (guanosine monophosphate) refers to a nucleotide used as one of the four monomers in RNA while cGMP (cyclic GMP) refers to a cyclic nucleotide derived from guanosine triphosphate . Number of Phosphate Groups. GMP contains a single phosphate group while cGMP has three, cyclic phosphate groups. Molecular Formula.  Function. Conclusion.

  Specification under batch  Process Pharama Industry:   Specifications  for  APIs  and pharmaceutical drug products, both chemical components and biologics, are vital  used  for product quality and patient protection. The goals of  specification  arrangements are  (1) to identify appropriate and safe limits or quantitative ranges during clinical development and  (2) to give  specifications  for the product to enter the market.

  Labelling API in Production Indusrry: Containers for APIs and API Intermediates should bear labels that give at least the following  information: - The name of the material, - Site material identification code, - Amount of material, - The batch or lot number, - The expiry date (if applicable), - Any special storage or handling conditions, and - The manufacturing site and contact information.   General Requirements for Labels  - Labels should be clear, unambiguous, and permanently affixed to containers  - Labels should follow an approved Site format, bear a label code number with revision  code - labelling in pharama Industry: The information on the label should be indelible   Minimum Requirements for Label Content - Identification Name(s), including International Nonproprietary Name (INN) if Applicable. - Grade (e.g. Sterile, Injectable, Veterinary) if applicable  - Site article number  - Manufacturer or re-packer lot number or batch numb...

  Samplin and Release of Raw Material in Pharma Industry:  Prepare  sampling  record  of raw material . Related: SOP for Retesting Schedule  of Raw Material  .  Testing  and Release  . Make entry of the received  sample  in  Raw Material  Log Register.  Distribute the  sample  for chemicals and instrumental analysis as per specifications.  Issue the photocopy of approved protocols. WHO guidelines for  sampling of pharmaceutical  products  and  related  materials  .  Introduction   General considerations   Glossary  Purpose of  sampling   Classes and types of  pharmaceutical  products  and  related  materials     Sampling  facilities   Responsibilities for  sampling    Health and safety  Sampling  .