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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

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to improve quality and costs significantly they are regulatory requirement in the

Pharmaceutical Industry has an average of 1200- 1300 SOPs

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DEFINITION CONTENTS BENEFITS

NEED WRITING STYLES PREPARATION REVIEW & APPROVAL

FREQUENCY OFREVISIONS AND REVIEWS IMPLEMENTATION MANAGEMENT FORMAT OF AN SOP

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a written step-by-step procedure

for an activitycarried out in aparticularorganization.

SOP

WHOM

WHAT

WHEN

WHERE

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Company name & address: Page no:

Title: SOP no:

Review no:

Review period:

Prepared by: Reviewed by: Approved by:

Objective:

Scope:

Responsibility:

Procedure:

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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)

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information necessary to perform a jobproperly

consistently to maintain quality controlof processes and products.

uninterrupted and are completed no failures

approved procedures training document for teaching users checklist an historical record

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NEED OF SOP

SOP-WRITING STYLES

PREPARATION OF SOP

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SOP REVIEW & APPROVAL

FREQUENCY OF REVISIONS

AND REVIEWS

IMPLEMENTATION

MANAGEMENT

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COMPRESSION,COATING ANDDISINFECTION

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Title: Standard operating procedure forequipment clearance compressionmachine(27 station)

Objective: To lay down a standard procedurefor equipment clearance compressionmachine(27 station)

Scope: To provide guidelines to ensure

effective line clearance of the area andequipment.

Responsibility: Operator, Production Officer

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

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

Ensure that all containers, documents and labels ofprevious product / batch are removed and statusboard is updated.

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Ensure that all the cervices and near by areais free from previous product.

Ensure that all the gloves and accessories ofprevious product/batch are removed.

Ensure that the punch set is fixed as perstandard specification of respective product.

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Check the cleanliness of the dedusting machine

Check the Temperature, Relative Humidity and

the Differential Pressure of the cubicle and enterthe same in the Batch Manufacturing Record.

Line clearance is given by Production Officer tostart the next batch, after checking the above-mentioned points, which is to be recorded in theBatch Manufacturing Record (BMR).

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After checking all above points and theBMR, Final Line Clearance should be givenby In Process Quality Assurance Officer.

Record the observations in the formatOUCT-PAQA: xxx

Enclosure:Line Clearance Checklist for CompressionMachine, format OUCT-PAQA: xxx

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Title: Standard operating procedure for gelatincoating 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 coat6-well plates for culture of Mouse EmbryonicFibroblasts (MEFs). This SOP can be modified ifother culture vessels require gelatin coating.

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Scope: This procedure applies to allMassachusetts Human Stem Cell Bank

laboratory personnel responsible for cultureof hESCs. Responsibility: It is the responsibility of the

Laboratory Operations Manager and Quality Assurance Officer to ensure all

laboratory personnel are properly trained inand follow this SOP.

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MATERIALS REQUIRED1. EQUIPMENT Sterile biosafety cabinet (tissue culture hood) 37C incubator Pipette-aid2. 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 Supplies71011000-3)3. REAGENTS0.1% gelatin solution (SOP-RP-001 Preparation of 0.1% Gelatin

Solution)

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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 papertowel.

7. Spray the surface of everything taken into the hood with ethanol. Dry them withpaper towels if needed.

2. ALIQUOT 0.1% GELATIN SOLUTION IN THE HOOD1. 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 for15-30 minutes.

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3. COAT CULTURE PLATES USING 0.1 % GELATIN SOLUTION1. 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 Initials3. 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 COATING1. Record necessary information on the Gelatin Coating and

Inactivated MEFSeeding and Culture Log Sheet.Note: The plates will be ready for use in 4 hours. They can be

used for up to 7 days.

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Title: Standard operating procedure for sterilearea disinfection

Objective: To lay down a standard procedure for

Sterile Area Disinfection Scope: This procedure provides a standardmethod for routine cleaning of sterile area usingDisinfectants to ensure the area is completelyfree from micro organisms

Responsibility: Senior Chemist - Production Supervisor - Production. House keeping

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Procedure: 1. Remove all glass pieces if any, fromsterile area after completion of the filling.

2. Clean the filling Machine, SS parts, filling table andfloor with distilled water.

3. Use hot distilled water to remove the strain ifpresent. Then use following disinfectants as per theschedule.

4. After cleaning, dry the sterile area for half an hour.

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5. The Machine, table, laminar airflow should be wipedwith decontaminating solution.Decontaminating solution contains:Liquid phenol 5% w/v

Formaldehyde 8% v/vIPA 75% v/vDistilled water QS

6. Spray the hydrogen peroxide solution 20% w/v after

cleaning and wiping.7. Finally, fumigate by using Formaldehyde and Potassiumpermanganate.

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http://www.colorcon.com/formulation/processes/film-coating#core_substrate_formulation

http://www.gmpqualityup.com/Titlelinks/GMP_Manufacturing_Procedures.pdf

SOP Guideline: Electronic Data ManagementAUTHOR: D. H. ShahPUBLISHER: Business Horizons

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