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PharmWeb GMP Forum
(by way of John Dolman<info@pharmweb.com>) | |||
| 29 Mar | RE: GMP Discussion Group Digest - 29/03/08 | ||
| 02 Apr | RE: responsibility of QA | ||
| 02 Apr | Validation / verification | ||
| 10 Apr | RE: Validation / verification | ||
(by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 30 Jun | Re: Online Audit | ||
| 05 Jul | Re: Online Audit | ||
| 17 Jul | Re: Online Audit | ||
| 17 Jul | Re: Online Audit | ||
| 19 Aug | RE: Working Standard | ||
| 26 Aug | PQ for reactor - API | ||
| 04 Sep | % recovery - Cleaning validation | ||
| 04 Sep | D form ampoules for injectables | ||
| 09 Sep | RE: % recovery - Cleaning validation | ||
| 25 Sep | RE: Blend Uniformity oral solid dosage forms | ||
(by way of John Dolman<moderator@the-dolman-consultancy.com>) | |||
| 07 Jan | RE: UV lamps | ||
| 19 Jan | RE: Post media fill cleaning | ||
| 22 Feb | Production closing procedure | ||
| 03 Mar | Printer verification | ||
| 12 Mar | CPP-API | ||
| 17 Mar | RE: Prefiltration bubble point determination. | ||
| 17 Mar | Swab from reactor? | ||
| 17 Mar | RE: CPP-API | ||
| 20 Mar | RE: Computer Validation | ||
| 26 Mar | Swab from reactor? | ||
=?big5?B?RnJlZGRpZSBZZWgtuK26Yb3l?= (by way of John Dolman <info@the-dolman-consultancy.com>) | |||
| 27 Jun | Process Validation Issue | ||
| 03 Oct | Shipping Validation | ||
| 03 Oct | RE: Batch Increase & Validation | ||
| 03 Oct | Batch Increase & Validation | ||
| 06 Oct | Batch Increase & Validation | ||
=?big5?B?RnJlZGRpZSBZZWgtuK26Yb3l?= (by way of John Dolman <moderator@the-dolman-consultancy.com>) | |||
| 19 Mar | RE: Sterilisation of Vent Filter in steam steriliser | ||
A. D'Emanuele | |||
| 02 Jan | Seasons Greetings | ||
Abhijit Singh Parmar" (by way ofJohn Dolman <moderator@the-dolman-consultancy.com>) | |||
| 05 Feb | GLP | ||
Afsar Shaikh" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 05 Dec | Depyrogenation of glassvials for terminally sterilized Product | ||
AG Kumar" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 02 Sep | Cold Room Validation | ||
| 04 Sep | Re: Cold Room Validation | ||
aks (by way of John Dolman <info@pharmweb.com>) | |||
| 29 Mar | Re: Reprocessing of drug product | ||
| 29 Mar | Re: GLP | ||
| 30 Mar | Re: Reprocessing of drug product | ||
| 11 Apr | Re: Validation / verification | ||
aks (by way of John Dolman<moderator@the-dolman-consultancy.com>) | |||
| 06 Feb | Re: GLP | ||
Alan Longworth" (by way of John Dolman<moderator@the-dolman-consultancy.com>) | |||
| 11 Jan | Question for the Forum | ||
Albertina Estrada" (by way of John Dolman<moderator@the-dolman-consultancy.com>) | |||
| 28 Feb | API | ||
Aleksandra" (by way of JohnDolman <moderator@the-dolman-consultancy.com>) | |||
| 08 Mar | HOLDING TIME and MEAN KINETIC TEMPERATURE | ||
Alex Liu" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 23 Jul | two manufacturing sites in one DMF | ||
| 31 Oct | skip testing or skip lot testing | ||
| 03 Nov | Re: skip testing or skip lot testing | ||
| 05 Nov | Re: skip testing or skip lot testing | ||
ambika" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 24 Nov | Upstream and downstream process ! | ||
Amer Almalakh (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 05 Jul | Re: in-process checks | ||
| 28 Nov | Re: Secondary packaging | ||
amr al-azhary | |||
| 27 Jan | maximum Hold time determination | ||
amr AL-azhary (by way of John Dolman<moderator@the-dolman-consultancy.com>) | |||
| 25 Feb | bioassay method validation | ||
anand" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 30 Jun | in-process checks | ||
| 05 Jul | Re: in-process checks -Malcolm Ross | ||
Anant Bapu" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 29 Sep | Cleaning validation | ||
| 01 Oct | Re: Cleaning validation | ||
| 05 Nov | Assigning expiration dates | ||
Anderton, Catherine" (by wayof John Dolman <info@the-dolman-consultancy.com>) | |||
| 15 Jul | RE: Significant figures | ||
Andrius Baikštis (by way of John Dolman <moderator@the-dolman-consultancy.com>) | |||
| 12 Mar | RE: Prefiltration bubble point determination. | ||
Angel Gutierrez" (by way of JohnDolman <info@pharmweb.com>) | |||
| 28 Mar | Validation of a Refrigerator or Freezer | ||
Angel Gutierrez" (by way of JohnDolman <info@the-dolman-consultancy.com>) | |||
| 26 Jun | Validation of a Laminar Flow Chamber | ||
Angel Gutierrez" (by way of JohnDolman <moderator@the-dolman-consultancy.com>) | |||
| 31 Jan | Validation of Analytical Method | ||
| 21 Feb | Re: HVAC validation | ||
| 08 Mar | Thermal Validation of Oven | ||
Anil" (by way of John Dolman<moderator@the-dolman-consultancy.com>) | |||
| 15 Jan | GMP requirements for immunosuppressant products | ||
Annie Macleod" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 06 Aug | RE: Product contact tubing and fittings | ||
Anoop Mamgain" (by way of John Dolman<moderator@the-dolman-consultancy.com>) | |||
| 13 Feb | Re: GMP Discussion Group Digest - 28/01/08 | ||
Anthony McMahon" (by way of JohnDolman <info@the-dolman-consultancy.com>) | |||
| 31 Aug | RE: Executed Batch Records - review-approval time | ||
Aravind Aithal" (by way of JohnDolman <moderator@the-dolman-consultancy.com>) | |||
| 24 Mar | RQ of Autoclave | ||
Aravind" (by way of John Dolman<info@pharmweb.com>) | |||
| 02 Apr | RQ Of Autoclave | ||
Arun Shankar" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 02 Aug | Validation | ||
Arun_Kumarapally@Relbio.com (by way of John Dolman) | |||
| 09 Sep | Re: % recovery - Cleaning validation | ||
| 16 Sep | Re: Background air for capping of aseptically-filled liquid vials | ||
| 25 Sep | Re: Recovery - Classified area | ||
| 08 Oct | Re: Shipping Validation | ||
| 05 Nov | Sample volume in area qualification | ||
| 24 Nov | Re: The concentration of H2O2. | ||
Arvind Gupta" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 20 Nov | RE: The consatration of H2O2. | ||
Arvind Kushwaha | |||
| 17 Apr | RE: PharmWeb Enquiry | ||
Arvind Kushwaha" (by way ofJohn Dolman <info@the-dolman-consultancy.com>) | |||
| 10 Nov | RE: Cleaning validation | ||
| 12 Nov | RE: Cleaning validation | ||
| 24 Nov | Comparability after scale up | ||
B.Anil Kumar Singh" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 24 Jul | Re: two manufacturing sites in one DMF | ||
| 06 Aug | Re: Process validation (Batch size change) | ||
| 09 Sep | Re: UV and HPLC analysis | ||
| 05 Oct | Re: Role of Regulatory affairs | ||
| 29 Oct | Re: regulatory | ||
Balu Balakrishnan" (by way of JohnDolman <moderator@the-dolman-consultancy.com>) | |||
| 08 Mar | CIP 300 | ||
Basant Mittal" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 19 Dec | cleaning efficacy validation of Disinfectants | ||
ben de greve" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 25 Nov | RE: Secondary packaging | ||
Benoit Chedhomme" (by way ofJohn Dolman <info@the-dolman-consultancy.com>) | |||
| 09 Oct | RE: Shipping Validation | ||
Bob Friedel" (by way of John Dolman<info@pharmweb.com>) | |||
| 09 Apr | RE: Validation of a Refrigerator or Freezer | ||
Bob Hayes" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 15 Jul | RE: sterile area recover | ||
| 05 Dec | RE: QA / QC Organisation | ||
Bob Kirsch" (by way of John Dolman<info@pharmweb.com>) | |||
| 28 Mar | RE: Stability Testing | ||
| 30 Mar | RE: Reprocessing of drug product | ||
| 31 Mar | RE: Stability Testing | ||
Bob Kirsch" (by way of John Dolman<info@the-dolman-consultancy.com>) | |||
| 29 Jun | RE: Release specifications Europe | ||
| 02 Aug | RE: Stability of opened containers | ||
| 26 Aug | RE: clarification of calculation of impurities. | ||
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MHonArc 2.3.3