General
Commission of the European Communities
Committee for Proprietary Medicinal Preparations (CPMP). 4. Analytical validation. Note for guidance. In: The rules governing medicinal products in the European Community. Brussels, CEC (III/844/87-EN, Final, August 1989; Addendum, July 1990).
Committee for Proprietary Medicinal Preparations (CPMP). 5, Investigation of bioavailability and bioequivalence. Note for guidance. In: The rules governing medicinal products in the European Community. Brussels, CEC (revised 1991; Volume III, Addendum No. 2, 1992).
Germany
Betriebsverordnung für pharmazeutische Unternehmer. [Factory regulations for pharmaceutical manufacturers.] Bonn, §5 and §6, Ministry of Health, 1985, and amendments (in German).
- Basic text: March 9, 1985. Bundesgesetzblatt, 1985, I:546.
- First amendment: March 25, 1988, Bundesgesetzblatt, 1988, I:840.
- Reunification Treaty: August 31, 1990. Bundesgesetzblatt. 1990, ll:885, 1084.
- Second amendment: July 13, 1994. Bundesgesetzblatt, 1994, I:1560.
- German Pharmaceutical Law, 5th amendment, Art. 4. No. 1. August 9, 1994, Bundesgesetzblatt, 1994. I:2071.
International Pharmaceutical Federation
Diding N et al. Komitee für Laboratorien und Offizielle
Medikamentenkontrolldienste und der Sektion der Industrieapotheker der FIP.
Guidelines for Good Validation Practice (GVP). In: Feiden K. Validation, FIP experience and application in the FR Germany. Drugs made in Germany. 1983, XXVI:80-85.
Feiden K. Betriebsverordnung für pharmazeutische Unternehmer, Rechtsvorschriften mit speziellen Begründungen, ergänzenden internationalen Richtlinien und einer Einführung. [Factory Regulations for Pharmaceutical Manufacturers, legal provisions with special explanations, complementary international guidelines and an introduction.] In: PIC-Richtlinien für die gute Validierungspraxis. [PIC guidelines on good validation practice], 3rd ed. Stuttgart, Deutscher Apotheker Verlag, 1991:109-112 (in German).
Richtlinien für die gute Validierungs-Praxis. [Guidelines on good validation practice.] Pharmazeutische Industrie, 1980, 42(10):982-984 (in German).
Nigeria
Good manufacturing practice for Nigerian pharmaceutical manufacturers. Lagos, Manufacturers' Association of Nigeria, 1991.
Pharmaceutical Inspection Convention
Validation. The collected papers given at a seminar held in Dublin from 14 to 17 June 1982. Geneva, PIC.
Sweden
Validation and qualification processes. Stockholm, Association of Swedish Pharmaceutical Industry [Läkemedelindustriföreningen], 1986.
United States Food and Drug Administration
General principles of validation. Rockville, MD, Center for Drug Evaluation and Research (CDER), 1987.
Validation of process and control procedures. Rockville, MD, CDER, 1994.
Guide to inspections of bulk pharmaceutical chemicals. Rockville, MD, CDER, 1994.
USSR (former)
Good manufacturing practices. Normative document. Moscow. Ministry of Medical Industry, 1991 (PD 64-125-91, in Russian).
World Health Organization
Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992:14-79 (WHO Technical Report Series, No. 823).
Miscellaneous
Barr DB, Crabbs WC, Cooper C. FDA regulation of bulk pharmaceutical chemical production. Pharmaceutical technology, 1993, 17(9):57-70.
Berry IR, Nash RA, eds. Pharmaceutical process validation, 2nd ed. New York, Marcel Dekker, 1993.
Broker CG. Validation in perspective. Journal of parenteral science and technology, 1981, 35(4): 167-169.
Khan MSP. Assurance of quality Pharmaceuticals. Total quality approach. Chittagong, Bangladesh, Signet Press, 1990.
Martinez ER. An FDA perspective on bulk pharmaceutical chemical GMPs, control and validation. Pharmaceutical engineering, 1994, 14(5/6):8-14.
Maynard DW. Validation master planning. Journal of parenteral science and technology, 1993, 47(2):84-88.
Sucker H. Praxis der Validierung. [Validation in practice.] Stuttgart, Wissenschaftliche Verlagsgesellschaft, 1983 (in German).
Process validation
Commission of the European Communities
Committee for Proprietary Medicinal Preparations (CPMP). Development pharmaceutics and process validation. Guidelines on the quality, safety and efficacy of medicinal products for human use. In: The rules governing medicinal products in the European Community, Vol. III. Brussels, CEC, 1989.
Germany
Arbeitsausschuss Phytopharmaka des Bundesverbandes der Pharmazeutischen Industrie. Leitlinien zur Herstellung und Analytik von Phytopharmaka. [Guidelines on the manufacture and analysis of phytopharmaceutics.] Pharmazeutische Industrie, 1989, 51(7):731-734 (in German).
Pharmaceutical Manufacturers Association, USA
Concepts for the process validation of bulk pharmaceutical chemicals. Washington, DC, Pharmaceutical Research and Manufacturers of America, 1993 (December): 34-40.
United States Food and Drug Administration
Guidelines on general principles of process validation. Rockville, MD, Center for Drug Evaluation and Research, 1987.
Miscellaneous
Akers J, McEntire J, Sofer G. Biotechnology product validation. Part I. Identifying the pitfalls. Pharmaceutical technology Europe, 1994, 6(2):32-34.
Berry I. Validation: practical applications to pharmaceutical products. Drug development and industrial pharmacy, 1988, 14(2&3):377-389.
Bias-lmhoff U, Glanzmann G, Woiwode W. Annual product review. Pharmazeutische Industrie, 1992, 54(2):177-182.
Chapman KG. The PAR approach to process validation. Pharmaceutical technology, 1984, 8(12):22-36.
Chiu YH. Validation of the fermentation process for the production of recombinant DNA drugs. Pharmaceutical technology, 1988, 12(6): 132-138.
Cipriano PA. Process validation begins with initial plant design. Pharmaceutical engineering, 1982, 2(3):2.
Loftus BT. Process validation. Pharmazeutische Industrie, 1980, 42(11a):1202-1205.
Melliger GW. Process validation - practical experience in industry. Pharmazeutische Industrie, 1980, 42(11a):1199-1202.
Morris JM. Development pharmaceutics and process validation. Drug development and industrial pharmacy, 1990. 16(11):1749-1750.
Sharp JR. The problems of process validation. The pharmaceutical journal, 1986, 1:43-45.
Validation of non-sterile processes
Feiden K. Validierung als Beitrag zur Arzneimittel-Sicherheit. [Validation as a contribution to the safety of medicines.] In: Qualifizierung und Validierung bei der Herstellung flüssiger und halbfester Arzneiformen. [Qualification and validation in the manufacturing of liquid and semiliquid finished dosage forms.] Heidelberg, Concept, 1987 (in German).
Simmons PL. Solid process validation. Pharmaceutical engineering, 1981, 1(4): 38-39, 41.
Thieme H. Implementation of a validation of equipment demonstrated on a Diosna P 600. Pharmazeutische Industrie, 1982, 44(9):919-924 (in German).
Validation of sterile processes
International Pharmaceutical Federation
FIP Committee on Microbial Purity. Validation and environmental monitoring of aseptic processes. Journal of parenteral science and technology, 1990, 44(5): 272-277; Pharmazeutische Industrie, 1990, 52(8):1001-1005 (in German); Pharmaceutica acta helvetica, 1990, 65(12):327-333 (in French).
United States Food and Drug Administration
Center for Drug Evaluation and Research (CDER). Guideline for submitting documentation for sterilization process validation in application for human and veterinary drug products. Federal register, 1993, 58(231, December 3): 63996-64002.
FDA-Richtlinie für mittels aseptischer Verfahren hergestellte Arzneimittel. [FDA guideline on sterile drug products produced by aseptic processing.] Pharmazeutische Industrie, 1987, 49(12):1237-1246. (in German).
Guideline on sterile drug products produced by aseptic processing. Rockville, MD, CDER, 1987.
Sterilization process validation. Recommendations for information to be submitted to human and veterinary drug applications. Rockville, MD, Center for Veterinary Medicine, CDER, 1993.
World Health Organization
Sterile pharmaceutical products [Section 17 of Good manufacturing practices for pharmaceutical products]. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992:59-72 (WHO Technical Report Series, No. 823).
Miscellaneous
Agalloco JP, Akers J. Current practices in the validation of aseptic processes -1992. Journal of parenteral science and technology, 1993, 47:S1 -S21.
Carleton FJ, Agalloco JP. Validation of aseptic pharmaceutical processes. New York, Marcel Dekker, 1986.
Carleton FJ et al. Design concepts for the validation of a water for injection system. Philadelphia, Parenteral Drug Association, 1983 (Technical Report No. 4).
Gail L, Wallhäusser KH, Klavehn M. Die Validierung von Trockenhitze-Sterilisatoren. [The validation of dry-heat sterilizers.] Pharmazeutische Industrie, 1982, 44:613-618 (in German).
Lingnau J. Standard versus non-standard sterilization processes. Pharmazeutische Industrie, 1991, 53(8):771-775.
Seyfarth H. Validation of aseptic filling for sterile drugs. Part 1. Sterile media fill. Pharmazeutische Industrie, 1987, 49(11):1176-1183 (in German).
Seyfarth H. Validation of aseptic filling for sterile drugs. Part 2. Environmental monitoring. Pharmazeutische Industrie, 1988, 50(7):851-863 (in German).
Simmons PL. The secret of successful sterilizer validation. Pharmaceutical engineering, 1980, 1(1):1.
Tetzlaff RF. Regulatory aspects of aseptic processing. Pharmaceutical technology, 1984, 8(11):38-44.
Wallhäusser KH. Validation procedure for control of sterilization by filtration. Pharmazeutische Industrie, 1982, 44(4):401 -404 (in German).
Validation of cleaning processes
Sweden
Validation of cleaning methods for process equipment in pharmaceutical manufacturing. Stockholm, Association of Swedish Pharmaceutical Industry [Läkemedelindustriföreningen], 1991.
United States Food and Drug Administration
Guide to inspections of validation of cleaning processes. Rockville, MD, Division of Field Investigation. 1993.
Miscellaneous
Adner N, Sofer G. Biotechnology product validation. Part 3: chromatography cleaning validation. Pharmaceutical technology Europe. 1994, 6(4):22-28.
Baseman HJ. SIP/CIP validation.1Pharmaceutical engineering: 1992, 12(2):37-46.
Fourman GL, Mullen MV. Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations. Pharmaceutical technology, 1993, 17(4):54-60.
LeBlanc DA, Danforth DD, Smith JM. Cleaning technology for pharmaceutical manufacturing. Pharmaceutical technology, 1993, 17(7):84-91
McCormick PY, Cullen LF. Cleaning validation. In: Berry IR, Nash RA, eds. Pharmaceutical process validation, 2nd ed. New York, Marcel Dekker, 1993: 319-349.
Seiberling DA. Alternatives to conventional process/CIP1 design -for improved cleanability. Pharmaceutical engineering, 1992, 12(2):16-26.
Smith JA. A modified swabbing technique for validation of detergent residues in clean-place systems. Pharmaceutical technology, 1992, 16(1):60-66.
Zeller AO. Cleaning validation and residue limits. A contribution to current discussions. Pharmaceutical technology, 1993, 17(10):70-78; Pharmaceutical technology international, 1993, 17(11):18-21.
1 CIP = Cleaning in place/position
SIP = Sterilizing/steaming in place/position
Validation of analytical procedures
World Health Organization
Validation of analytical procedures used in the examination of pharmaceutical materials. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva. World Health Organization, 1992:117-121 (WHO Technical Report Series. No. 823).
Miscellaneous
Grimm W, Schepky G. Stabilitätsprüfung in der Pharmazie. [Stability testing in pharmacy] Aulendorf, Germany, Editio Cantor. 1980:335-348 (in German).
Lachman L et al. Quality control charts. In: The theory and practice of industrial pharmacy. Philadelphia, Lea & Febiger, 1986:817-824.
Quality control methods. In: Remington's pharmaceutical science, 18th ed. Easton, PA, Mack, 1990:128-129.
Seely RJ et al. Validation of chromatography resin useful life. In: Biotechnology product validation, part 7. Pharmaceutical technology Europe, 1994, 6(11):32-38.
Validation of computerized systems and computer-assisted processes
United States Food and Drug Administration
A guide to inspection of software development activities (the software lifecycle). Rockville, MD, Center for Drug Evaluation and Research (CDER), 1987.
CDER. Guide to inspection of computerized systems in drug processing. Pharmaceutical industry, 1983, 1:39-68.
Computerized drug processing: source code for process control application programs. Compliance Policy Guide No. 7132a. 15. Federal register, 1987, 52(95):18612.
Guidance manual: CANDA, computer assisted new drug applications. Rockville, MD, CDER, 1992:1-103.
Points to consider: computer assisted submissions for license applications. Rockville, MD, Center for Biologics Evaluation and Research, 1990.
Software development activities, reference materials and training aids for investigators. Rockville, MD, Division of Field Investigations, 1987.
Miscellaneous
Christ GA, Unkelbach H-D, Wolf H. Computer-Validierung. [Computer validation.] Pharmazeutische Industrie, 1993, 55(7):640-644.
Fry EM. FDA regulation of computer systems in drug manufacturing. Pharmaceutical engineering, 1988, 8(5):47-50.
Geschwandtner R et al. Validation of computer-assisted production processes in pharmaceutical manufacturing. Pharmazeutische Industrie, 1989, 51(8):911 -913.
Isaacs A. Validation machinery with electronic control systems. Manufacturing chemistry, 1992, 2:19-27.
Kuzel NR. Fundamentals of computer system validation and documentation in the pharmaceutical industry. Pharmaceutical technology, 1985, 9(9):60-76.
Motise PJ. What to expect when FDA audits computer-controlled processes. Pharmaceutical manufacturing, 1982, 7(7):33-35.
Passing H, Unkelbach H-D. Software-Validierung aus dem Blickwinkel der GLP-bzw. GMP-Richtlinien. [Software validation from the point of view of GLP or GMP guidelines.] Pharmazeutische Industrie, 1987, 49(6):590-595 (in German).
Tetzlaff RF. GMP documentation requirements for automated systems. Part I. Pharmaceutical technology, 1992, 16(3): 112-124.
Tetzlaff RF. GMP documentation requirements for automated systems. Part II. Pharmaceutical technology, 1992, 16(4):60-72; Pharmaceutical technology international, 1992, 16(9):30-38.
Tetzlaff RF. GMP documentation requirements for automated systems. Inspections of computerized laboratory systems. Part III. Pharmaceutical technology international, 1992, 16(10):36-50.
Loading...
