GMP tips and SOP training for the employees.

1.0.            OBJECTIVE:  

To provide procedure for GMP tips for the employees.

2.0.            SCOPE:

This procedure is applicable for explaining GMP tips to the employee.

3.0.            RESPONSIBILITY:

3.1.            QA manager is responsible for verifying adhering and implementing the SOP.

4.0.            PROCEDURE:

4.1.            Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.

4.2.            There shall be a sufficient number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

4.3.            Never bypass safety rules.

4.4.            Read and observe all labels, signs, and so on.

4.5.            Be especially careful around breaks, when you are tired, are called away, and so on.

4.6.            Wear appropriate clothing. Do not wear or take clothing or work shoes out of work area.

4.7.            Keep things clean. Wash your hands.

4.8.            Report illness/not feeling well.

4.9.            Use only released raw materials, packaging components, labels, and so on.

4.10.        Check that equipment is clean and/or sterile before using it.

4.11.        Only use equipment within calibration.

4.12.        Always write in information where requested, or write “N/A” in blank spaces. Fill in completely and thoroughly.

4.13.        Record results as you get them.

4.14.        Use indelible black ink pen. Do not use pencil, correction fluid, or felt-tip pens.

4.15.        Line through, initial, and date any changes.

4.16.        Follow your company’s data recording rules. Attach original data.

4.17.        Never backdate or falsify records.

4.18.        Ask supervisor if you have any questions. There is no such thing as a dumb question. Please do not assume.

4.19.        You deserve the time to think, despite what’s going on around you, and regardless of how big a rush is.

4.20.        Please take action to make things better.

4.21.        Record ID numbers, part numbers, lot numbers.

4.22.        Remember: no food, gum, tobacco (or houseplants) in production or laboratory areas.

4.23.        Double-check the transfer of data. Before signing, check multiplication/calculations.

4.24.        Print clearly in equipment logs and laboratory notebooks; fill them out completely.

4.25.        Have another person properly perform verifications or double-checks where indicated.

4.26.        Keep shipping and other doors closed.

4.27.        During an inspection, answer all questions honestly and directly. Do not speculate or volunteer information. Refer any questions to your supervisor.

4.28.        Properly perform line clearances.

4.29.        When performing calibration and preventive maintenance, use appropriate standards, forms, equipment logbooks, and labels. Document thoroughly. Help ensure that equipment is maintained on time.

4.30.        Never simply average out-of-specification (OOS) results to obtain a passing result. Follow your company’s SOP on handling OOS results.

4.31.        Report mistakes or possible mistakes as soon as possible to your supervisor. If you deviate, document it and let your supervisor or manager know immediately.

4.32.        Read and become familiar with all SOPs, batch records, forms, Material Safety Data Sheets (MSDS), and other documents concerning your work. Offer to revise outdated ones, or create needed ones.

4.33.        Document all on-the-job training. Ensure that you have a current job description, and/or offer to create or revise it. (Refer: SOP-QAD-022-02).

5.0.            ANNEXURE:

Nil

6.0.            REFERENCES:

SOP-QAD-022-02

7.0.            ABBREVIATION:

Abbreviation used       Full form of abbreviation used

QA                              Quality Assurance

GMP                           Good Manufacturing Practice

SOP                             Standard Operating Procedure

N/A                             Not Applicable

ID                                Identification

OOS                            Out of Specification

MSDS                         Material Safety Data Sheet

8.0.            DISTRIBUTED:

Quality Assurance

Manufacturing

Warehouse

HR& Administration

Engineering

9.0.            REVISION HISTORY:

Revision No.	Change Control Number	Reason for the Modifications