Healthy Healing dba Crystal Star USFDA warning Letter 1/11/18 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Wong Lap Kwong Medicine Company Limited USFDA warning Letter 1/11/18 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Beauty Manufacturing Solutions Corp. USFDA warning Letter 1/12/18 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Daito Kasei Kogyo Co Ltd USFDA warning Letter 1/18/18 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Polaroisin International Co., Ltd. USFDA warning Letter 1/25/18 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Celltrion Inc. USFDA warning Letter 1/26/18 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Cosmecca Korea Co., Ltd. USFDA warning Letter 2/2/18 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Imprimis Pharmaceuticals USFDA warning Letter 12/21/17 For Warning Letter Click Here –   For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Continental Manufacturing Chemist, Inc. USFDA warning Letter 12/21/17 For Warning Letter Click here –     For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Investra-24hs USFDA warning Letter WARNING LETTER The United States (U.S.) Food and Drug Administration (FDA) recently reviewed your websites (listed at the bottom of this letter) and determined that they offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed …

Casmara Cosmetics, S.A. USFDA warning Letter 2/21/18 For Warning Letter Click the Link –  Casmara Cosmetics, S.A. 2/12/18 For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Questions and answers EU GMP guide annexes: Supplementary requirements 1. How should the integrity of sterilising filters be verified? H+V June 2007 Annex 1, paragraph 85 states, ‘the integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such …

Questions and answers Basic requirements for active substances used as starting materials: GMP compliance for active substances 1. How can GMP compliance for active-substance manufacturers be demonstrated? H+V April 2011 Directive 2001/83/EC as amended (Directive 2001/82/EC for veterinary medicinal products) states that manufacturing-authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured …

Questions and answers on Data integrity Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems. Promotion of a quality culture together with implementation …

Deviation Handling and Quality Risk Management Purpose The aim is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations.  The intent is to support the effective and timely implementation of tools related to deviation management …

Human interventions in aseptic processing It is appropriate to focus on human interventions performed during aseptic processing because no other factor has the same potential for introducing contamination. Sterilization processes, environmental sanitization, room design, and heating and ventilation systems are all substantially less significant as sources of contamination. Personnel continuously shed microorganisms and particles to …

Non-sterile process validation as per WHO Technical Report Series, No. 937 1. Principle 2. Scope 3. General 4. Prospective validation 5. Concurrent validation 6. Retrospective validation 7. Revalidation 8. Change control Principle Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the …

Validation of computerized systems 1. General 2. System specification 3. Functional specification 4. Security 5. Back-ups 6. Validation 7. Validation of hardware and software 7.1 Hardware 7.2 Software General Computer systems should be validated at the level appropriate for their use and application. This is of importance in production as well …

Analytical method validation as per WHO Technical Report Series, No. 937 Principle General Pharmacopoeial methods Non-pharmacopoeial methods Method validation Characteristics of analytical procedures Principle This appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in this appendix may be followed …

Cleaning validation protocols Cleaning validation should be described in cleaning validation protocols,which should be formally approved, e.g. by the quality control or quality assurance unit. In preparing the cleaning validation protocol, the following should be considered: — disassembly of system — precleaning — cleaning agent, concentration, solution volume, water quality — time …