These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
137 related articles for article (PubMed ID: 8000897)
1. Role of quality control in validation of biopharmaceutical processes: case example of clean-in-place (CIP) procedure for a bioreactor. Geigert J; Klinke R; Carter K; Vahratian A PDA J Pharm Sci Technol; 1994; 48(5):236-40. PubMed ID: 8000897 [TBL] [Abstract][Full Text] [Related]
2. Quality control and good manufacturing practices: safety and efficacy of commercial herbals. Awang DV Food Drug Law J; 1997; 52(3):341-4. PubMed ID: 10343036 [No Abstract] [Full Text] [Related]
3. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium. Allison G; Cain YT; Cooney C; Garcia T; Bizjak TG; Holte O; Jagota N; Komas B; Korakianiti E; Kourti D; Madurawe R; Morefield E; Montgomery F; Nasr M; Randolph W; Robert JL; Rudd D; Zezza D J Pharm Sci; 2015 Mar; 104(3):803-12. PubMed ID: 25830179 [TBL] [Abstract][Full Text] [Related]
4. Appropriate specifications at the IND stage. Geigert J PDA J Pharm Sci Technol; 1997; 51(2):78-80. PubMed ID: 9146038 [TBL] [Abstract][Full Text] [Related]
5. Aseptic processing contamination case studies and the pharmaceutical quality system. Friedman RL PDA J Pharm Sci Technol; 2005; 59(2):118-26. PubMed ID: 15971544 [TBL] [Abstract][Full Text] [Related]
6. Current good manufacturing practice: proposed revision of certain requirements for finished pharmaceuticals; proposed rule, May 3, 1996 (61 FR 20103), [Docket No. 95N-0362]. Parenteral Drug Association. PDA J Pharm Sci Technol; 1996; 50(6):346-51. PubMed ID: 9038078 [No Abstract] [Full Text] [Related]
8. FDA perspective on specifications for biotechnology products--from IND to PLA. Murano G Dev Biol Stand; 1997; 91():3-13. PubMed ID: 9413677 [TBL] [Abstract][Full Text] [Related]
9. The integration of process analytical technologies, concurrent validation, and parametric release programs in aseptic processing: Parenteral Drug Association. Korczynski MS PDA J Pharm Sci Technol; 2004; 58(4):181-91. PubMed ID: 15368988 [TBL] [Abstract][Full Text] [Related]
10. Pharmaceutical GMPs. Bobrowicz G Qual Assur; 1994 Jun; 3(2):138-48. PubMed ID: 7804629 [No Abstract] [Full Text] [Related]
14. Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective. Murphy M; Bell BL; Moshi J; Grassi R; Forng RY; Salaman A; Jordi PW; Zaidi S; Goodnight M; Paul M; Keller A; Carpenter B; Hearty U; Willison-Parry D PDA J Pharm Sci Technol; 2018; 72(2):213-221. PubMed ID: 29444992 [TBL] [Abstract][Full Text] [Related]
15. Quality assessment of recombinant proteins produced in plants. Medrano G; Dolan MC; Condori J; Radin DN; Cramer CL Methods Mol Biol; 2012; 824():535-64. PubMed ID: 22160919 [TBL] [Abstract][Full Text] [Related]
16. [Cleaning of machines for pharmaceutical production: microbiological investigation to establish validation procedures]. Anastasio P; Carazzone M; Genova R; Malesani L; Molinari ML Boll Chim Farm; 1987 Mar; 126(3):116-20. PubMed ID: 3689577 [No Abstract] [Full Text] [Related]
17. Raw material considerations. Lubiniecki AS; Shadle PJ Dev Biol Stand; 1997; 91():65-72. PubMed ID: 9413684 [TBL] [Abstract][Full Text] [Related]
18. As Genzyme flounders, competitors and activist investors swoop in. Allison M Nat Biotechnol; 2010 Jan; 28(1):3-4. PubMed ID: 20062016 [No Abstract] [Full Text] [Related]
19. Report on the PQRI impurity characterization and quantification best practices survey. Faustino P; Chan CC; Carrano J; Gosnell M; Gu ZQ; Maule A; Sigvardson K; Zhang YF Pharm Res; 2006 Feb; 23(2):440-6. PubMed ID: 16477396 [No Abstract] [Full Text] [Related]
20. Cleaning validation of ofloxacin on pharmaceutical manufacturing equipment and validation of desired HPLC method. Arayne MS; Sultana N; Sajid SS; Ali SS PDA J Pharm Sci Technol; 2008; 62(5):353-61. PubMed ID: 19055231 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]