Call for Articles
Up to Articolo per Pharmaceutical Engineering
Riporto il testo del messaggio ricevuto da ISPE, relativo alla richiesta di materiale da pubblicare. Ho messo in evidenza alcuni possibili punti che potremmo sviluppare: il ruolo del fornitore nelle attività di Commissioning & Qualification, la produzione e manutenzione dei documenti, esempi concreti.
25 September 2006
Dear Sandro,
Pharmaceutical Engineering is issuing an international call for articles to
professionals engaged in Commissioning and Qualification. The May/June 2007
issue focuses on current trends in the integration of commissioning and
qualification and we need articles by subject matter experts like you! Potential
articles could explore effective C&Q team setup, incorporation of the vendor
in the C&Q process, and the implementation of the [new] ASTM standard.
Articles are needed that investigate how to effectively manage the C&Q
process, the commissioning of indirect and no impact systems, the use of
commissioning and qualification concepts with computerized systems, as well as
the assembly and maintenance of GMP documentation and turnover packages. Case
studies providing examples of specific commissioning and qualification
activities would also benefit the issue.
Potential article topics of interest would include: Time Saving Techniques,
Trends, Management of the C&Q Activity, Indirect Impact Systems, Team
Setup/Vendor Management, Peripheral support facilities, CSV/GAMP,
Documentation/Turnover Packages, Maintaining GMP Documentation/Turnover
Packages, ASTM Standard, How to meet new ASTM vendor expectations.
The deadline for receiving articles for this issue is 3 January
2007.
For your assistance, please review our Author Guidelines which include a link to instructions for
submitting your manuscript via our web-based manuscript submission and
peer-review program; Manuscript Central®. If you need additional
information or would like to suggest a topic for this issue, please contact the
Editor, Gloria
Hall.
We appreciate your assistance with this initiative and look forward to
hearing from you.
Sincerely,
| Phil Pursifull | Steve Wisniewski |
| Senior Engineer | Senior Associate, Director of Compliance |
| Commissioning Agents Inc. | IPS |
|
Members, ISPE Editorial Committee |