INTRODUCTION SOP DEFINITION CONTENTS BENEFITS NEED WRITING STYLES PREPARATION REVIEW & APPROVAL FREQUENCY OF REVISIONS AND

REVIEWS IMPLEMENTATION MANAGEMENT FORMAT OF AN SOP SAMPLE SOPS SOPs FOR COMPRESSION SOPs FOR COATING SOPs FOR DISINFECTION CONCLUSION

to improve quality and costs significantly they are regulatory requirement in the Pharmaceutical Industry has an average of 1200- 1300 SOPs

DEFINITION CONTENTS BENEFITS NEED WRITING STYLES PREPARATION REVIEW & APPROVAL FREQUENCY OF REVISIONS AND REVIEWS IMPLEMENTATION MANAGEMENT FORMAT OF AN SOP

a written step-bystep procedure for an activity carried out in a particular organization.

WHOM

WHERE

SOP

WHAT

WHEN

Company name & address: Title:

Page no: SOP no: Review no: Review period:

Prepared by:

Reviewed by:

Approved by:

Objective: Scope: Responsibility: Procedure:

What is the objective of SOP (Purpose) What are applicability and use of SOP (Scope)? Who will perform tasks (Responsibility) Who will ensure implementation of procedure (Accountability) How tasks will be performed (Procedure)

information necessary to perform a job properly consistently to maintain quality control of processes and products. uninterrupted and are completed no failures approved procedures training document for teaching users checklist an historical record

NEED OF SOP

SOP-WRITING STYLES
PREPARATION OF SOP

SOP REVIEW & APPROVAL FREQUENCY OF REVISIONS AND REVIEWS IMPLEMENTATION

MANAGEMENT

COMPRESSION,COATING AND DISINFECTION

Title: Standard operating procedure for equipment clearance compression machine(27 station) Objective: To lay down a standard procedure for equipment clearance compression machine(27 station) Scope: To provide guidelines to ensure effective line clearance of the area and equipment. Responsibility: Operator, Production Officer

Procedure: Ensure that the area is cleaned as per SOP: OUCTxxx

Ensure that the Compression Machine is cleaned as per the SOP: OUCT-PAQA: xxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: OUCT-PAQA: 008/A; Point No: 3.2, for Product change over/ Expiry of use before date.

Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.

Ensure that all the cervices and near by area is free from previous product. Ensure that all the gloves and accessories of previous product/batch are removed. Ensure that the punch set is fixed as per standard specification of respective product.

Check the cleanliness of the dedusting machine

Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. Line clearance is given by Production Officer to start the next batch, after checking the abovementioned points, which is to be recorded in the Batch Manufacturing Record (BMR).

After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
Record the observations in the format OUCT-PAQA: xxx Enclosure: Line Clearance Checklist for Compression Machine, format OUCT-PAQA: xxx

Title: Standard operating procedure for gelatin coating of culture plates Objective: Human Embryonic Stem Cells (hESCs) are cultured on gelatin-coated plates. Gelatin is a translucent, colorless solid substance extracted from animal collagen. This Standard Operating Procedure (SOP) describes how 0.1% gelatin solution is used to coat 6-well plates for culture of Mouse Embryonic Fibroblasts (MEFs). This SOP can be modified if other culture vessels require gelatin coating.

Scope: This procedure applies to all Massachusetts Human Stem Cell Bank laboratory personnel responsible for culture of hESCs. Responsibility: It is the responsibility of the Laboratory Operations Manager and Quality Assurance Officer to ensure all laboratory personnel are properly trained in and follow this SOP.

MATERIALS REQUIRED 1. EQUIPMENT Sterile biosafety cabinet (tissue culture hood) 37C incubator Pipette-aid 2. SUPPLIES 6-well tissue culture plates (Costar 3516) 5 ml sterile serological pipettes (Costar 4487) 10 ml sterile serological pipettes (Costar 4488) Sterile Pasteur pipettes (Fisher 13-678-20D) Disposable nitrile gloves (World Wide Medical Supplies 71011000-3) 3. REAGENTS 0.1% gelatin solution (SOP-RP-001 Preparation of 0.1% Gelatin Solution)

Procedure: 1. STERILIZATION PREPARATION BEFORE WORKING IN THE HOOD 1. Wash hands and arms thoroughly (about one minute) with soap. 2. Rinse completely with tap water. 3. Dry hands and arms with paper towel. 4. Put on appropriate-size gloves. 5. Spray 70% ethanol on the gloves and a paper towel until totally wet. 6. Thoroughly clean the working surface in the hood with the ethanol-sprayed paper towel. 7. Spray the surface of everything taken into the hood with ethanol. Dry them with paper towels if needed. 2. ALIQUOT 0.1% GELATIN SOLUTION IN THE HOOD 1. Take the bottle of 0.1% gelatin solution from the refrigerator and place it in the hood after cleaning it with 70% ethanol. 2. According to the volume calculated in Section 2.1, do the following: Label an appropriate-size sterile tube or bottle as GS for gelatin solution. Transfer an appropriate amount of gelatin solution to the labeled tube or bottle. 3. Place the GS tube or bottle in a 37C water bath or 37C room for 15-30 minutes.

3. COAT CULTURE PLATES USING 0.1 % GELATIN SOLUTION 1. Place the plates that are to be coated in the hood. 2. Label the cover of the plate (not over the wells) with: G for gelatin Date Initials 3. For 6-well plates, add 2 ml of 0.1% gelatin solution to each well. 4. Tilt the plates in several directions so that the liquid covers the entire surface area. 5. Place the plates in a 37C incubator. 4. POST GELATIN COATING 1. Record necessary information on the Gelatin Coating and Inactivated MEF Seeding and Culture Log Sheet. Note: The plates will be ready for use in 4 hours. They can be used for up to 7 days.

Title: Standard operating procedure for sterile area disinfection Objective: To lay down a standard procedure for Sterile Area Disinfection Scope: This procedure provides a standard method for routine cleaning of sterile area using Disinfectants to ensure the area is completely free from micro organisms Responsibility: Senior Chemist - Production Supervisor - Production. House keeping

Procedure: 1. Remove all glass pieces if any, from sterile area after completion of the filling.
2. Clean the filling Machine, SS parts, filling table and floor with distilled water. 3. Use hot distilled water to remove the strain if present. Then use following disinfectants as per the schedule. 4. After cleaning, dry the sterile area for half an hour.

5. The Machine, table, laminar airflow should be wiped with decontaminating solution. Decontaminating solution contains: Liquid phenol 5% w/v Formaldehyde 8% v/v IPA 75% v/v Distilled water QS
6. Spray the hydrogen peroxide solution 20% w/v after cleaning and wiping. 7. Finally, fumigate by using Formaldehyde and Potassium permanganate.

http://gmponblog.vinvarun.biz/2009/04/cleaning-ofcompression-machine-27.html http://gmponblog.vinvarun.biz/2008/10/disinfectantefficacy-test-by-swabing.html http://gmponblog.vinvarun.biz/2008/11/efficacytesting-of-disinfectants.html http://www.colorcon.com/formulation/processes/filmcoating#core_substrate_formulation http://www.gmpqualityup.com/Titlelinks/GMP_Manuf acturing_Procedures.pdf SOP Guideline: Electronic Data Management AUTHOR: D. H. Shah PUBLISHER: Business Horizons