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Pharmaceutical Science

Monday, May 5, 2008. CASE STUDY : GMP INSPECTION PROCESS. CASE STUDY No.1. The company is still developing their integrated quality management system which will be compiled in a quality manual. You observed the following issues:. 1 The company’s quality control programme was unacceptable. 111 There was no documented regular calibration programme. 112 There was no evidence that thermometers were calibrated. 116 The calibration SOPs lacked acceptance limits and action clauses. 121 The (product active) meth...

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Pharmaceutical Science | pharmaceuticalscience-science.blogspot.com Reviews

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Monday, May 5, 2008. CASE STUDY : GMP INSPECTION PROCESS. CASE STUDY No.1. The company is still developing their integrated quality management system which will be compiled in a quality manual. You observed the following issues:. 1 The company’s quality control programme was unacceptable. 111 There was no documented regular calibration programme. 112 There was no evidence that thermometers were calibrated. 116 The calibration SOPs lacked acceptance limits and action clauses. 121 The (product active) meth...

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1 pharmaceutical science

2 gmp inspection process

3 the inspection

4 the scene

5 observations

6 for example

7 11 calibration

8 16 training

9 17 stability

10 18 laboratory environment

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Pharmaceutical Science | pharmaceuticalscience-science.blogspot.com Reviews

https://pharmaceuticalscience-science.blogspot.com

Monday, May 5, 2008. CASE STUDY : GMP INSPECTION PROCESS. CASE STUDY No.1. The company is still developing their integrated quality management system which will be compiled in a quality manual. You observed the following issues:. 1 The company’s quality control programme was unacceptable. 111 There was no documented regular calibration programme. 112 There was no evidence that thermometers were calibrated. 116 The calibration SOPs lacked acceptance limits and action clauses. 121 The (product active) meth...

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pharmaceuticalscience-science.blogspot.com

1

Pharmaceutical Science: May 2008

http://pharmaceuticalscience-science.blogspot.com/2008_05_01_archive.html

Monday, May 5, 2008. CASE STUDY : GMP INSPECTION PROCESS. CASE STUDY No.1. The company is still developing their integrated quality management system which will be compiled in a quality manual. You observed the following issues:. 1 The company’s quality control programme was unacceptable. 111 There was no documented regular calibration programme. 112 There was no evidence that thermometers were calibrated. 116 The calibration SOPs lacked acceptance limits and action clauses. 121 The (product active) meth...

2

Pharmaceutical Science: CASE STUDY : GMP INSPECTION PROCESS

http://pharmaceuticalscience-science.blogspot.com/2008/05/case-study-gmp-inspection-process.html

Monday, May 5, 2008. CASE STUDY : GMP INSPECTION PROCESS. CASE STUDY No.1. The company is still developing their integrated quality management system which will be compiled in a quality manual. You observed the following issues:. 1 The company’s quality control programme was unacceptable. 111 There was no documented regular calibration programme. 112 There was no evidence that thermometers were calibrated. 116 The calibration SOPs lacked acceptance limits and action clauses. 121 The (product active) meth...

3

Pharmaceutical Science: April 2008

http://pharmaceuticalscience-science.blogspot.com/2008_04_01_archive.html

Tuesday, April 29, 2008. Inspection of pharmaceutical manufacturers. Inspection of pharmaceutical manufacturers1. The guidelines also have relevance in various other contexts, including:. 8226; self-inspection or internal audit of a factory or a part of it carried out by personnel of the company;. 8226; inspection by an independent person or group of persons as a review of the quality system of a company in compliance with the standards issued by the International Organization for Standardization (ISO 90...

4

Pharmaceutical Science: RESAMPLING SOFTWARE FOR ANALYSIS AND VALIDATION OF ENUMERATIVE AND BINOMIAL SAMPLING PLANS

http://pharmaceuticalscience-science.blogspot.com/2008/04/resampling-software-for-analysis-and.html

Monday, April 28, 2008. RESAMPLING SOFTWARE FOR ANALYSIS AND VALIDATION OF ENUMERATIVE AND BINOMIAL SAMPLING PLANS. Resampling Software for Analysis and validation of enumerative and binomial sampling plans. Steven E. Naranjo. Western Cotton Research Laboratory, USDA-ARS, Phoenix, AZ. William D. Hutchison. Department of Entomology, University of Minnesota, St. Paul, MN. RESAMPLING FOR VALIDATION OF SAMPLE PLANS. Tn ³ (an1-b/D2)1/(2-b). Tn ³ (a 1)/(D2 - [b - 1]/n). Wald’s SPRT: Wald’s (1947) s...Where x i...

5

Pharmaceutical Science: Inspection of pharmaceutical manufacturers

http://pharmaceuticalscience-science.blogspot.com/2008/04/inspection-of-pharmaceutical.html

Tuesday, April 29, 2008. Inspection of pharmaceutical manufacturers. Inspection of pharmaceutical manufacturers1. The guidelines also have relevance in various other contexts, including:. 8226; self-inspection or internal audit of a factory or a part of it carried out by personnel of the company;. 8226; inspection by an independent person or group of persons as a review of the quality system of a company in compliance with the standards issued by the International Organization for Standardization (ISO 90...

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Pharmaceutical Science

Monday, May 5, 2008. CASE STUDY : GMP INSPECTION PROCESS. CASE STUDY No.1. The company is still developing their integrated quality management system which will be compiled in a quality manual. You observed the following issues:. 1 The company’s quality control programme was unacceptable. 111 There was no documented regular calibration programme. 112 There was no evidence that thermometers were calibrated. 116 The calibration SOPs lacked acceptance limits and action clauses. 121 The (product active) meth...

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