Precautions for Preparing SOP’s
Instructions and Procedures should be written in a clear language, specifically applicable to the facilities provided. Records are make in such a way that during manufacturing process, it will show that all the steps required by the defined procedures and instructions have in –fact been taken and that the quantity and quality of the product is as expected. Any significant expected deviation are fully recorded and investigated.
Documents required are to be designed, prepared, received and distributed with such a care that it will comply with the relevant parts of the manufacturing and operating procedures as well as facilities available. Documents will be approved, signed and dated by appropriate authorised persons and person nominated by the management.
Persons Having Authority may include
i. Nominee of local staff, expert in his own field and familiar with Good Manufacturing Practices
ii. E.D (Operations)
iii. Manager Quality Control
iv. Manager Quality Assurance
v. E.D. (Technical)
1. Documents must not be changed, amended or added to without authorisation.
2. Documents should have the title, code number, superceded number, date of issue and effective date as well as the purpose should be clearly stated.
3. Documents should be laid out in an orderly fashion and be easy to check; critical steps should be highlighted.
4. Reproduced documents should be clear and legible. The reproduction of working documents from the master documents must not allow any error to be introduced throughout the reproduction process.
5. Documents should be regularly reviewed and kept up to date. When a document has been revised by the team, effective date of corrected version is given and previous suspended documents should be preserved for at least one year after the expiry date of the last batch made on it.
6. To prevent inadvertent use of the superceded version, dispose off the documents after the expiry period, in the presence of persons listed above. Till the time these are disposed off, they are kept separately under lock and key in the control of QC department.
7. Any alteration made to a document will be signed and dated by all the above persons who are authorised to do so. The alteration will permit the reading of the original information, where appropriate, the reason for the alteration will be recorded.
8. One original copy each of Master Formula Cards, Standard operating Procedures and specifications should be stored in lock, one copy should be retained with each member who signed that document and one copy is required to be kept at each concerned department. Whenever necessary, it should be displayed at respective area and retained by concerned person of production, technical supervisor, QA chemist and QC Chemists.
9. All the records should posses particular code numbers to identify it and should be easily accessible with respective department.
10. Reference number is given to each document and supporting document. For example, SOP in association with master formula card, is given the same sub-code, which refers to that master formula card only.
Validity : Till further amendment / revision