by 1.0 OBJECTIVE
To lay down a procedure for the preparation and approval of art works
2.0 SCOPE
This SOP is applicable for approval of art works.
3.0 RESPONSIBILITY
3.1 Head- purchase and planning shall be responsible for:
3.1.1 Coordinating designing of artwork.
3.2 Quality Assurance (QA) shall be responsible for:
3.2.1 Checking and reviewing of artwork design.
3.3 Head, Quality Assurance shall be responsible for:
3.3.1 Authorization of art work design.
3.4 The designated person of contract giver shall be responsible for:
3.4.1 Organizing preparation of artwork design
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE
5.1 Text matter for artwork shall be given to Head-Purchase & Planning department by the Designated personnel of the contract givers.
5.2 On the basis of text matter, marketing design & suitability of space in required size, artwork shall be made & sent to the formulation plant for approval.
5.3 QA shall receive the Artwork and make entry in the Artwork Register.
5.4 QA shall check the Artwork with respect to adequacy in the following aspects:
5.4.1 Artwork Size and scale
5.4.2 Text matter (Covering the requirement as per Rule 96 of Drugs & Cosmetic Act 1945 – for Domestic Preparation) which are as follows:
- Name of the Product
- Generic name of the Product.
- Composition / Formula.
- Ingredients & Pharmacopoeia Standard.
- Colour & Excipients.
- Dosage.
- Storage.
- Schedule H and H1 Warning if any.
- Red line min. 1mm. Thickness if any.
- Direction for use if any.
- Quantity of capsules or pack size.
- Provision for
- Mfg. License No.
- B. No.
- Mfg. Date
- Expiry Date
- Maximum Retail Price
- Checking of spelling mistakes, if any.
- 5.4.3 Mention the points of corrections and after putting signature, date and remark “Artwork to be corrected” shall be sent back to the Head, Purchase & Planning Department and who in turn shall further forward the same to the party.
- 5.5 QA shall receive “Corrected Artwork” and follow steps from 4.3 to 4.4.4 till the artwork is rectified and correct.
- 5.6 If found correct the artwork shall be approved by QA by putting signature, date & remark “Approved”.
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees: Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8.0 ATTACHMENT
Nil
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
