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Phar Pharma mace ceut utic ical al Guid Guidel elin ines es:I :ISO SO,, FDA, FDA, USFD USFDA, A, ICH ICH,, WHO, WHO, GMP GMP,, MHRA MHRA gui guide deli line ne,, Valid Validat atio ion n Proto Protoco col, l, SO… SO…
USFDA guidelines, guidelines, G MP guidelines, WHO guidelines, Schedule M , FDA, European guidelines cleaning validation, process validation, water water system validation, ICH guidelines, GM P audut compliance, compliance, equipment qualification, Installation Qualification, Qualification, Ope rational Qualification, Qualification, Pe rformance rformance Qualification, Calibration, Validation Validation Protocol, SOPs etc.
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If you are associated with pharmaceutical pharmaceutical prof profession ession i.e. quality control, quality assurance, regulatory affairs affairs or pharmaceutical production then you need to know about recent updates about pharmaceutical pharmaceutical guidelines. W e provide provide you these updates about cGMP, WHO, USFDA, ICH, MCC, TGA, MCA, MHRA, Schedule M, c linical trials and all other regulatory pharma guidelines 2012, pharma product formulation development. It will help to all pharmaceutical professionals and freshers who want to enter in pharmaceutical profession. Freshers will also get calibration of all inst ruments and equipments equipments and other useful information. information. We regularly write over this s ite on all pharma pharmaceutical ceutical t opics on Production, Quality Control, Quality assurance and regulatory affairs. affairs. We als o c ov over er the pharmaceutical validations and qualifications, Pharmaceutical Production SOPs and Current Current Good Manufacturing Practices in pharmaceutical pharma ceutical produ production. ction. So, keep watching this this site regularly. Ads by Google Quality Control Drug Testing Lab Quality Assurance Pharmaceutical Upcomming Articles: FDA regulations clinical trials, FDA va validation lidation guidelines, guidelines, 21 cfr part 11 c ompliance, GMP compliance, FDA compliance, FDA audit, Pharma manufacturing, Regulatory affairs, Medical device validation, GMP validation, 21 cfr part 820, Regulatory affairs, Clinical trial FDA, HPLC Method Validation, FDA validation, Validation Control, Contro l, Regulatory compliance, HVAC validation, Water sy stem.
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GMP Audit Check List- Filling Filling an d Packag ing 1. Do the packaging operations proceed following the instructions and using the specified materials described in the Master Pac kaging Procedure?
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2. Are 2. Are the detai details ls of the the operat operation ion recorde recorded d on the Batch Batch Packagin Packaging g Record? Record? 3. Is only one product batch and packaging size on a line at any given time? 4. Are 4. Are all deli deliveri veries es of bulk bulk produ product ct and packag packaging ing componen components ts checked and veri verified fied for their their correctness correctness against the Master Packaging Procedure of other specific order? 5. Is the first precoded packaging compound checked on the correctness of the printed codes? 6. Are 6. Are componen components ts allocated allocated for pre-codi pre-coding ng stored stored in in sealed sealed containe containers rs within within an appro appropria priate te area area for for proper security and segregation? 7. Does pre-coding of components take place in an area isolated form other packaging operations? 8. Are 8. Are all pre-cod pre-coded ed components components checked checked again against st the correctness before before transfer to packagi packaging? ng? 9. Are 9. Are there procedu procedures res describing describing a. receipt and identification of bulk ,packaging components? b. proper control to assure the correct, printed and unprinted packaging component used? c. the required in-process control? d. the reconciliation of bulk products and printed packaging materials? final package examination? Line clearance
10. Before a packaging operation starts, are checks carried out to ensure that work area and equipment are clean and free form a. any products? b. product residues? Or c. documents not required for that operation? 11. Is an inspection conducted of each line prior to packaging to ensure
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a. removal of all previous drug product and labeling materials? b. general cleanliness of the line and the imm ediate area? c. cleanliness of the equipment to be used? Employed 12. Is there inspection verified by Quality Control? In-process control
13. Are there procedures for in-process control describing, a. the point of sampling? b. the frequency of sampling? c. number of samples to be taken? d. specification to be checked? e. the limit of acceptability for each specification? 14. Does the in-process control include; a. checking of the product till or count at the start of the packaging run? b. checking of the finished products through-out the run at regular intervals for their full compliance with specifications? c. checking of batch identity through-out the packaging operation? 15. Are the results of in-process tests and inspection a. recorded? b. included in the Batch Packaging Record? Operating practices
16. Is there adequate separation of packaging lines to prevent any mix-up? 17. Is each packaging line identified with product name, pack, size and batch number? 18. Are storage containers for a bulk product, partly packed product or sub-batch labeled and marked with; a. product identity? b quantity? C batch number? d status? 19. Are the empty containers to be filled supplied to packaging line or station in a clean c ondition? Pharma Guidelines on Twitter
20. Are printed packaging materials found during clean-up a. turned over to the supervisor in the packaging area?
b. placed in special designated containers (for reconciliation and destruction at the end of packaging run)? Pharma 21. Are finished or semi-finished packages observed off the packaging a. given to the supervisor of the pac kaging?
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b. never returned directly to the packaging line? c. scrapped and the amount recorded, if the package cannot be identified for the same batch or lot number? olabaybee
22. Are products filled into their final containers and awaiting labeling and final packaging segregated and marked with the; a. product identification? b. batch number?
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c. status? your email here... 23. Are measures taken to control the spread of dust during packaging especially of enter dry products by;
a. using dust collecting device? b. discouraging use of compressed air? 24. Is a segregated area provided for filling and packaging of potent low dose or toxic products or sensitizing agents?
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25. Is use of brushes discouraged?
MHRA-UK Guideline s
26. Is bringing personal medicament into the pac kaging area prohibited?
MCC Guidelines -South Africa
27. Is placing of packaging components or products in the pocket of the personnel prohibited?
TGA Guidelines-Australia
28. Are supplies like lubricants, adhesive, inks, c leaning fluids etc. kept in
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a. a container different form the use for drug containers?
Schedule M-India
b. clearly labeled as to their contents?
European Guidelines
Completion of the packaging operation
MEDSAFE Guidelines -Newzela nd
29. Is the last production package carefully checked to confirm with specification on completion of the packaging operation?
GCC Guidelines -Gulf
30. Is only finished products form a single packaging operation placed in a pallet?
PANDRH Guideline s -American
31. Is the quantity of the partly filled carton indicated accordingly?
PIC/S Guidelines
32. Is inspection performed on each line after the packaging operations, to ens ure that
IPEQ Guidelines
a. all excess packaging components
Drugs & Cosmetics Act-India
b. remaining bulk product, or
APIC Guidelines
c. rejected packaging components
EU Guidelines
PDMA Guidelines -Japan
33. are removed, and after reconciliation closely supervised to ensure that only save and properly
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identified packaging components and bulk products are permitted to be returned to the w arehouse? 34. Are all excess or rejected coded packaging materials a. counted?
b destroyed under control of the supervisor?
35. Are quantities destroyed recorded on the Batch Packaging Record? 36. Is the net used packaging components and bulk products calculated and recorded by the supervisor? 37. Is any significant unexplainable yield discrepancy or failure to comply with s pecification thoroughly investigated? 38. Is the investigation extended to other batches or other products which might also be affected? 39. Are finished products quarantined until final release by Quality Control? 40. Is the removal of excess packaging component and bulk products after reconciliation closely supervised? Recommend this on
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► two thousand and eleven (two hundred fortyseven) ▼ 2012 (21) ► January (6) ► February (2) ► March (4) ► April (5) ▼ May (4) Non-sterile Process Validation in Pharmaceuticals Clean Room Sys tem in Sterile Pharmaceutical GMP Audit Check List- W eighing and Dispensing GMP Audit Check List- Filling and Packaging
What is 21 CFR ? This is the code for Fedra l Regula tions, sush as 1,2,3,...21,....40 etc. Those Numbers has different Headings such as 21 CFR- Food and Drug. These Headings has chapters I,II,III e tc. There are parts in every CFR, like Part 211 is of Current Good Manufacturing Practices or Finished Pharmaceutical s of the CFR 21. Again part is divided into the subparts as A,B,C,D....Z. Subparts are divide d into vari ous sections,It is a part no. with sr.no. such as section 211.1 USFDA guideline or Finished Pharmaceutical Products is given under 21 CFR part 210 and 211.
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