November 2016 ARTICLE LIST >>
PharmaTutor (November - 2016)
ISSN: 2347 - 7881
(Volume 4, Issue 11)
Received On: 03/06/2016; Accepted On: 21/06/2016; Published On: 01/11/2016
AUTHORS:
Nirav R.Soni,
Dept.of Qualtiy Assurance (QA)
A-one Pharmacy college,Enasan, Gujarat, India
nirav_sonic@yahoo.com
ABSTRACT: The specifications are to assure that each unit has the value of drug claimed on the label, that all the drug in each unit is out there for whole use, that the drug steady within the formula in its certain final container for their expected shelf life and it’s having no toxic overseas substance. It’s greatly utilized in pharmaceutical enterprise and utilized by using wellness sector and support best which is finished via GMP, GLP and GCP and other organization including Pharmaceutical Quality System (PQS) , Quality Risk Management (QRM) and Quality by Design (QbD).
How to cite this article: Soni N; Specifications for Starting Materials, Intermediates and Finished Products; PharmaTutor; 2016; 4(11); 21-26
[ABSTRACT WITH CITATION] [VIEW AS HTML]
REFERENCES:
1.John Geigert, The Center for Professional Innovation and Education (CfPIE) [Online] Available from: URL: https://www.cfpie.com/ProductDetails.aspx?ProductID=204
2.R.J. Timko et al., "Drug Substance Starting Materials: A Regulatory Perspective on Requirements and Selection," poster presented at American Association of Pharmaceutical Scientists Annual Meeting, Nashville, TN, [cited 2005 Nov].
3.ICH Q8 Pharmaceutical Development ; Geneva, Switzerland; [cited 2006 May].
4.ICH Q9 Quality Risk Management (Geneva, Switzerland, [cited 2006 June ].
5.FDA, Guidance for Industry: BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Post approval Changes: Chemistry, Manufacturing, and Controls Documentation, Feb. 2001, withdrawn, Fed. Regist. Notice [cited 2006 June 1].
6.FDA, Guidance for Industry: Drug Substance: Chemistry, Manufacturing, and Controls Information, Jan. 2004, withdrawn Fed. Regist. Notice [cited 2006 June 1].
7.ICH Q7 Good Manufacturing Guide For Active Pharmaceutical Ingredients, Geneva, Switzerland, [cited 2001 August].
8.FDA, Guidance for Industry: Guidance for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances ; Rockville, MD, [cited 1987 Feb].
9.FDA, Guidance for Industry: Changes to an Approved NDA or ANDA, Rev. 1 Rockville, MD, [cited 2004 Apr].
10.EMEA Committee for Proprietary Medicinal Products, Guidance on the Chemistry of New Active Substances, CPMP/QWP/130/96, Rev 1 ; London, England, [cited 2003 Dec 17].
11.EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II, Basic Requirements for Active Substances used as Starting Materials (Brussels, Belgium, Oct. 2005).
12. EDQM Division Certification of Substances, Public Document PA/PH/Exp. CEP/T (06) 35, "Certification of Suitability of Monographs of the European Pharmacopoeia. How Can the Content of the Applications for a Certificate of Suitability for Chemical Purity Be Improved? The Top 10 Deficiencies found in applications"; Strasbourg, France [cited 2006 Dec].
13.MHLW, Pharmaceutical and Food Safety Bureau, Guidelines on Mentions in Manufacturing / Marketing Approval Application Dossiers for Pharmaceuticals and Others Based on Revised Pharmaceutical Affairs Law, PFSB/ELD 020001 Tokyo, Japan, [cited 2005 Feb 10].
14.FDA, Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach, Final Report; Rockville, MD [cited 2004 Sep].
15.ICH Q3A R2 Impurities in New Drug Substances Geneva,Switzerland [cited 2006 June ].
16.ICH Q3C Impurities: Residual Solvents (Geneva, Switzerland, Dec. 1997, and ICH Q3C Tables and Lists, Rev. [cited 2005 Nov 3].
17.ICH Q6A Specifications: Test Procedures and Acceptance Criteria For New Drug Substances and New Drug Products: Chemical Substances Geneva, Switzerland [cited 1999 Oct].
18.L. Muller et al., "A Rationale for Determining, Testing, and Controlling Specific Impurities in Pharmaceuticals That Possess Genotoxicity, "Regulatory Toxicology & Pharmacology 44:198–211, 2006.
19.EMEA Committee for Medicinal Products for Human Use, Guideline on the Limits of Genotoxic Impurities, CPMP/SWP/5199 London, England, [cited 2006 June 28].
20.Code of Federal Regulations, Title 21, Food and Drugs, Volume 3, Chapter 1, Subpart B: Food Additive Safety, Section 170.39: Threshold of Regulation for Substances Used in Food-Contact Articles ; General Services Administration, Revised [cited 2007 Apr 1].
21.D. Jacobson-Kram and T. McGovern, 'Toxicological Overview of Impurities in Pharmaceutical Products," Advanced Drug Delivery Reviews 59 (1) :38–42, 2007.
22.Potdar Manohar A. “Pharmaceutical quality assurance through CGMP , documentation and validation”, Nirali prakashan , (1):355-360
23.P.P.Sharma,” How to practice GMPs”, vandana publication (6):58-62
24.Essential Medicines and Health Products Information Portal.Available from: URL: http://apps.who.int/medicinedocs/en/cl/CL1.1/clmd,50.html
25.Kenneth E. Avis, Herbert A. Lieberman, and Leon Lachman , Marcel Dekker INC “Pharmaceutical dosage forms: Parentral medications”, 3(2) :58-62 .
26.Herbert A. Lieberman, Leon Lachman and Joseph B. Schwartz , Marcel Dekker INC “Pharmaceutical dosage forms: Tablets”,1(2):548-551.
27.Herbert A. Lieberman, Martin M.Rienger, and Gilbert Banker Marcel Dekker INC “Pharmaceutical dosage forms: Disperse system”, 3(2), 457-465.
28.National Pharmaceutical Control Bureau, Ministry of Health Malaysia :1-20
Available from :URL:
http://bpfk.moh.gov.my/images/Guidelines_Central/Guidelines_on_Veterinary/Guidelines-on-GMP-for-Veterinary-Premixes-January-2015.pdf
29.Graham T. Illing, Linda Billett, Robert J. Timko, “Drug Substance Starting Material Selection Pharmaceutical Technology”, 32( 12) , [cited 2008 Dec 2]