QCS-003 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 7

3.5 attachment form

abc Pharmaceutical comPany

LEVEL 4

SOP No.: QCS-003

Issued On:

Revision No.:

Initiator:

ATTACHMENT I
BULK RELEASE

Product name: Batch No.: Code:

Manufacturing date: Expiry date:

Manufacturing
- Ampoules ▭ Content ▭ Physical parameters

- Capsules ▭ Dissolution ▭ Content (Assay)

- Cream ▭ Content

- Drops ▭ Content

- Ointment ▭ Content

- PPS ▭ Content

- Suppositories ▭ Content ▭ Content uniformity

- Suspensions ▭ Content ▭ Content uniformity

- Syrups ▭ Content ▭ Physical parameters (pH, refractive index, etc.)

- Tablets/caplets ▭ Granules ▭ Core ▭ Coated ▭ Content uniformity

- Vials ▭ Content

- Others ▭ Content

Remarks*

Date: Time: Name & Signature:

QC No.: Date: Time: Signature:

Physical Testing

Analyzed by: Date: Time:

Chemical Testing

Analyzed by: Date: Time:

▭ Released for packaging ▭ Not release for packaging

Checked by: QC officer Approved by: QC manager

* Other specific test needed