PRODUCT CHANGE OVER PROCEDURE SOPS


PRODUCT CHANGE OVER PROCEDURE SOPS


1.0   PURPOSE

To avoid the product mix up & cross contamination as per cGMP.

2.0  SCOPE

This procedure is to be followed for change over of products for manufacturing operations.

3.0  RESPONSIBILITY

Ø  Incharge Pharmacist
Ø  Production Manager
Ø  Quality Assurance Manager

4.0   PROCEDURE

Ø  At completion of manufacturing operations, dismantle the machine.
Ø  Remove (if any) left over powder, bottles, vials, seals, capsules etc. from the area.
Ø  Clean and sanitize / sterilize / disinfect the machine parts and area as per relevant for next day.
Ø  Adjust / assemble the required sterilized / sanitized / disinfected machine parts & check the machine for proper assembling.
Ø  When satisfactory prepare the area / machine as per relevant SOP for next day operation.
Ø  Inform Quality Control Department to perform area monitoring test for viable and non-viable particles.
Ø  Next product will only be processed if area is cleared by the Quality Control Department.


5.0   QUALITY FORMS AND RECORDS

Line clearance records are attached in BMR.

6.0   DISTRIBUTION

Ø  Head of Operation
Ø  Q.A Manager
Ø  Production Manager
Ø  Q.C Manager
Ø  Production Pharmacist

6 comments:

  1. According to the review directed for the current year, it has been accounted for by 71 percent of respondents that their all out pay (counting reward, compensation and even different advantages) had expanded over the time of a year. ExcelR PMP Certification

    ReplyDelete
  2. Truly, this article is really one of the very best in the history of articles. I am a antique ’Article’ collector and I sometimes read some new articles if I find them interesting. And I found this one pretty fascinating and it should go into my collection. Very good work!ExcelR pmp certification

    ReplyDelete
  3. Attend The PMP Certification in Abu Dhabi From ExcelR. Practical PMP Certification in Abu Dhabi Sessions With Assured Placement Support From Experienced Faculty. ExcelR Offers The PMP Certification in Abu Dhabi.
    ExcelR PMP Certification in Abu Dhabi

    ReplyDelete
  4. I am sure that this is going to help a lot of individuals. Keep up the good work. It is highly convincing and I enjoyed going through the entire blog.

    Data Science Course

    ReplyDelete
    Replies
    1. Thanks you are always welcome

      Delete
  5. I have bookmarked your website because this site contains valuable information in it. I am really happy with articles quality and presentation. Thanks a lot for keeping great stuff. I am very much thankful for this site.

    Data Science Training

    ReplyDelete