DESIGN PLANNING PROFORMA

Purpose:

It is established for Design Planning Proforma

2. Scope:

This procedure is applicable to R&D department.

3. Responsibilities:

1. Manager R&D
2. R&D Pharmacist

4. Procedure:
1. This proforma is useful for planning of the work to be completed within specified period of time.
2. The name of the product, design No., trial batch No., target date along with objectives are mentioned on the proforma.
3. Work break down structure like dispensing date, batch processing date, QC testing methods, design or trial reviews, etc. are mentioned.
4. Documents used like product specification, standard manufacturing procedure, request for analyses, etc. are mentioned.
5. All interfaces are documented. The department involved QA, QC & Production must be documented and mentioned to avail facilities on the said date.
6. Carbon copies to all concerned departmental heads are sent as prior information.
7. This design planning proforma must be approved by Manager R&D.