“PROCESS VALIDATION OF SOLID DOSAGE FORM …
“VALIDATION OF CRITICAL STEPS INVOLVED IN MANUFACTURING
OF LIQIUD ORAL DOSAGE FORM IN PHARMACEUTICAL INDUSTRY”
DISSERTATION PROTOCOL
SUBMITTED TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
BY
SUNIL K
M.PHARM, PART-I
DEPARTMENT OF QUALITY ASSURANCE
NARGUND COLLEGE OF PHARMACY
BANGALORE-85
(2009-2011)
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
|1. |NAME OF THE CANDIDATE |SUNIL K |
| |AND ADDRESS (IN BLOCK LETTERS) |NARGUND COLLEGE OF PHARMACY, |
| | |DATTATREYANAGAR, II MAIN, |
| | |100 FEET RING ROAD, |
| | |BSK III STAGE, |
| | |BANGALORE-85, |
| | |KARNATAKA. |
|2. |NAME OF THE INSTITUTION |NARGUND COLLEGE OF PHARMACY, |
| | |DATTATREYANAGAR, II MAIN, |
| | |100 FEET RING ROAD, |
| | |BSK III STAGE, |
| | |BANGALORE-85, |
| | |KARNATAKA. |
|3. |COURSE OF STUDY AND SUBJECT |MASTER OF PHARMACY IN |
| | |QUALITY ASSURANCE |
|4. |DATE OF ADMISSION OF COURSE | |
| | |1st JUNE 2009 |
| | | |
| | |“VALIDATION OF CRITICAL STEPS INVOLVED IN MANUFACTURING OF LIQIUD ORAL |
|5. |TITLE OF TOPIC |DOSAGE FORM IN PHARMACEUTICAL INDUSTRY” |
| | | |
| | |
|6. |Brief resume of the intended work: |
|6.1 |Need for the study: |
| |Quality cannot be inspected or tested into finished product. Thereby each step must be controlled to maximize probability that |
| |finished products meets all specification. |
| |There are several important reasons for validating a product and/or process; manufacturers are required by law to conform to cGMP|
| |regulations. Good business dictates that a manufacturer avoids the possibility of rejected or recalled batches. Validation helps |
| |to ensure product uniformity reproducibility and quality. |
| |In pharmaceutical industry validation has become a necessary step to ensure that you are maintaining quality of medicinal product,|
| |throughout manufacturing, storage, handling and distribution environment 1. |
| |Hence, there is need to validate process involved in manufacturing of pharmaceuticals. In this work, process validation of |
| |manufacturing of liquid orals is planned at the site of production. |
| | |
| |Review of literature: |
|6.2 |Process Validation (PV) is the documented evidence that the process, operated within established parameters, can perform |
| |effectively and reproducibly to produce an intermediate or active pharmaceutical ingredient (API) meeting its predetermined |
| |specifications and quality attributes. |
| |There are three approaches to validation: - |
| |Prospective validation should normally be performed for all API operations/process those are critical to the quality and purity of|
| |the API. |
| |Concurrent validation can be conducted when data from replicate production runs are unavailable because only a limited number of |
| |API |
| | |
| |batches have been produced, API batches are produced infrequently, or API batches are produced by a validated process that has |
| |been modified. |
| |An exception can be made for retrospective validation for well-established processes that have been used without significant |
| |changes to API quality due to changes in raw materials, equipment, systems, facilities, or the production process 2. |
| |Literature survey reveals that there are efficient methods to measure the parameters that control the quality of product and this |
| |will help for process validation studies. |
| |O. Okhamafe et al. gave an overview of pharmaceutical validation and process controls in drug development. It has always been |
| |known that facilities and processes involved in pharmaceutical production impact significantly on the quality of the products. The|
| |processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in GMP. |
| |The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it. Thus |
| |validation is an integral part of quality assurance 3. |
| | |
| |M.B. Brown et al. discussed a novel laser diffraction particle sizing system for hydrofluoroalkane (HFA) pressurized metered dose |
| |inhalers. The median volume diameter obtained using laser diffraction of both the salbutamol sulphate and fluticasone propionate |
| |suspended either in 2H, 3H-decafluoropentane or perfluoropentane was over one-order of magnitude larger than the particle sizes of|
| |the drugs suspended in HFA 134a 4. |
| | |
| |Westerhuis et al. developed simple assessment of homogeneity in pharmaceutical mixing processes. Determination of homogenous |
| |mixing of active pharmaceutical ingredient (API) is an important in-process control within the manufacturing of solid dosage |
| |forms. In this paper two new near-infrared based methods were presented; a qualitative and a quantitative method. Both methods are|
| |based on the calculation of net analyte signal (NAS) models which were very easy to develop, |
| | |
| |specific with respect to the API and required no additional reference analysis 5. |
| | |
| |G.A. Zachariadis et al. developed a rapid multi-element method of analysis of antitussive syrups by inductively coupled plasma |
| |atomic emission spectrometry and direct sample introduction. A new method was developed and optimized for routine multi-element |
| |determination of traces of metals in antitussive syrups using direct introduction of diluted syrup into the nebulization system of|
| |inductively coupled plasma atomic emission spectrometer (ICP-AES). Using a Scott-type double-pass spray chamber combined with a |
| |cross-flow nebulizer, the optimum ICP conditions, like RF incident power, argon gas flow rate and nebulizer sample uptake flow |
| |rate were found. A critical objective of the study was to evaluate the matrix effect on the intensity and consequently on the |
| |sensitivity of developed method 6. |
| | |
| |Mei-Ling Chen worked on lipid excipients and delivery systems. This review discusses some regulatory considerations in the use of |
| |lipid excipients and delivery systems for pharmaceutical development. Implications in the regulatory determination of |
| |pharmaceutical equivalence, bioequivalence and therapeutic equivalence are also illustrated7. |
| | |
| |Joseph Wong et al. worked on suspensions for intravenous (IV) injection. This article reviews various challenges associated with |
| |developing intravenous nano-suspension dosage forms, various formulation considerations specific to intravenous nano-suspensions |
| |and various clinical studies 8. |
| | |
| |Linda M Thienpont analyzed an analytical method development should aim at delivering reliable measurements within a given |
| |application. This implies that method validation is integrated in the development process because it enables to establish method |
| |performance capabilities and demonstrate its fitness for the purpose 9 |
| | |
|6.3 |Objectives of the study: |
| |Process validation is establishing documented evidences which provide high degree of assurance that a specific process will |
| |consistently produce a product meeting its predetermined specification and quality characteristics. |
| |The objective of the present work is to validate critical steps involved in manufacturing of liquid orals at Juggat |
| |Pharmaceuticals, Bangalore. |
| | |
| |Materials and Methods |
|7. |Materials and equipments will be used which are involved in liquid orals manufacturing of the particular product at JUGGAT PHARMA |
| |LIMITED, Mysore road, Bangalore. |
| |Source of data: |
| |Data will be obtained from Science direct, Pubmed, Pharmainforma, Medline, 3pdf and other internet facilities, literature search |
|7.1 |and related articles from library of Nargund College Of Pharmacy and digital library of Rajiv Gandhi University Of Health Science.|
| |A. Journals and articles: |
| |Tropical journal of pharmaceutical research |
| |European journal of pharmaceutics and biopharmaceutics |
| |International journal of pharmaceutics |
| |Journal of pharmaceutical and biomedical analysis |
| |Journal of chromatography B |
| |Analytical chemical acta |
| |Pharmaceutica acta helvetiae |
| | |
| |B. Internet browsing:- |
| |sciencedirect,com |
| | |
| | |
| |helinet.jccc.in |
| | |
| | |
| |.au |
| | |
| | |
| |C. Text books and guidelines:- |
| |Robert A. Nash and Alfred H. Wachter, “Pharmaceutical process validation”, third edition, CBS publishers. |
| |International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH |
| |harmonised tripartite guideline, “Good manufacturing practice guide for active pharmaceutical ingredients” Q7, current step 4 |
| |version dated 10 November 2000. |
| |P.P. Sharma, “How to practice GMPs”, fifth edition, Vandana publications. |
| |Manohar A. Potdar, “Pharmaceutical quality assurance”, second edition, Nirali prakashan publishers. |
| | |
| | |
| | |
|7.2 |Method Of Collection Of Data :- |
| |The process validation includes: |
| |Identification of the process in manufacturing of liquid orals. |
| |Decision of number process runs for validation. For prospective and concurrent validation, three consecutive successful |
| |production batches will be used. |
| |Identification of device(s) in manufacturing of liquid orals. |
| |Objective and measurable criteria in manufacturing of liquid orals. |
| |Length, duration , shifts, operators, equipment in manufacturing of liquid orals. |
| |Identification of utilities for the process equipment and quality of the utilities. |
| |Complete description of the process. |
| |Relevant specifications that relative to the product, components manufacturing materials, etc. |
| |Any special controls or conditions to be placed on proceeding processes during the validation. |
| |Process parameters to be monitored and methods for controlled and monitoring. |
| |Product characteristics to be monitored and method for monitoring (Physical and/ or chemical analysis). |
| |Any subjective criteria like sampling, sample analysis used to evaluate the product. |
| |Statistical method for data collection and analysis. |
| | |
| | |
| |Does the study require any investigation or intervention to be conducted on patients or other humans? if so please mention |
| |briefly. |
| |-NOT APPLICABLE- |
| |Has ethical clearance been obtained from your institution in case of 7.3? |
| |-NOT APPLICABLE- |
|7.3 | |
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|7.4 | |
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|8. |LIST OF References: |
| | |
| |Nash RA and Wachter AH. Pharmaceutical process validation. CBS publishers, 3rd ed: 159-90. |
| |International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH |
| |harmonised tripartite guideline, “Good manufacturing practice guide for active pharmaceutical ingredients” Q7, current step 4 |
| |version, dated 10 November 2000:27-30. |
| |Jatto E, Okhamafe AO. An overview of pharmaceutical validation and process controls in drug development. Trop J Pharm Res 2002; 1:|
| |115-22. |
| | |
| |Jones SA, Martin GP, Brown GM. High-pressure aerosol suspensions—A novel laser diffraction particle sizing system for |
| |hydrofluoroalkane pressurized metered dose inhalers. Int J Pharm 2005; 302: 154–65. |
| |Skibsted ETS, Boelens HFM, Westerhuis JA, Witte DT, Smilde AT . Simple assessment of homogeneity in pharmaceutical mixing |
| |processes using a near-infrared reflectance probe and control charts. J Pharm Biomed Anal 2006; 41: 26–35. |
| |Zachariadis GA, Kapsimali DC. Development of a rapid multi-element method of analysis of antitussive syrups by inductively coupled|
| |plasma atomic emission spectrometry and direct sample introduction. J Pharm Biomed Anal 2006; 41: 1212–19. |
| |Chen M. Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective. Advanced Drug Delivery |
| |Reviews 2008; 60: 768–77. |
| |Wong J, Brugger A, Khare A, Chaubal M, Papadopoulos P, Rabinow B, Kipp J et al. Suspensions for intravenous (IV) injection: A |
| |review of development, preclinical and clinical aspects. Advanced Drug Delivery Reviews 2008; 60: 939–54. |
| |Stockl D, D’Hondt H, Thienpont LM. Method validation across the disciplines-Critical investigation of major validation criteria |
| |and associated experimental protocols. J Chromatogr B 2009; 877: 2180-90. |
|9. |Signature of the candidate | |
| | | |
| | | |
| | | |
| | |(SUNIL K) |
|10. |Remarks of the Guide |RECOMMENDED FOR THE DISSERTATION WORK. |
|11. |Name & Designation of (in block letters) | |
| |Guide |MR. RAJESH ANTONY |
| | |ASSISTANT PROFESSOR, |
| | |DEPARTMENT OF QUALITY ASSURANCE, |
| | |NARGUND COLLEGE OF PHARMACY. |
| |11.2 Signature | |
| | |MR. RAJESH ANTONY |
| |Co-guide |MR. VENKATESH GS |
| | |DGM-QA, JUGGAT PHARMACEUTICALS,BANGALORE |
| | | |
| | |MR. VENKATESH GS |
| |Signature | |
| |11.3 Head of the department |DR. J.N. NARENDRA SHARATH CHANDRA |
| | |PROFESSOR ,HEAD OF THE DEPARTMENT |
| | |DEPARTMENT OF QUALITY ASSURANCE, |
| | |NARGUND COLLEGE OF PHARMACY. |
| |11.4 Signature | |
| | |DR. NARENDRA SHARATH CHANDRA |
|12. | 12.1 Remarks of Principal |FORWARDED AND RECOMMENDED FOR |
| | |FAVOURABLE CONSIDERATION. |
| |12.2 Signature. | |
| | |PROF. M.S.HARISH |
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