SOP On Facility Designing and Qualification


1.0 Objective

To define the Standard Operating Procedure for Facility Designing and Qualification.

2.0 Scope

2.1 This SOP is applicable for pharmaceutical Facilities.

2.1.1 When designing new facility.

2.1.2 Revamping of existing facility.

3.0 Responsibility

3.1 User Department

3.2 Engineering & Utility Department

3.3 Project Department

4.0 Accountability

4.1 Head Projects

4.2 Head QA

5.0 Abbreviations and Definitions:

SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

URS : User Requirement Specification

6.0 Procedure

6.1 Design development of facility shall be carried out prior to construction of the new facility or revamping of the existing facility and the approach consisting of following steps.

6.1.1 Facility URS

6.1.2 Conceptual study

6.1.3 Preparation and Approval of drawings and specifications

6.1.4 Construction

6.1.5 Facility qualification

6.2 Facility URS is the initial document prepared during the initial stage of the Project.

6.3 Conceptual document is prepared based on the Facility URS, which contains the design philosophy required to proceed to the next phase of the development.

6.4 Following are the general GMP requirements but not limited to, which shall be built into the facility during designing

6.4.1 The flow of materials & personal through the building or facilities should be designed to prevent mix-ups or contamination.

6.4.2 Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate.

6.4.3 Proper drainage system should be provided.

6.4.4 There should be adequate arrangement for disposal of wastewater and other residues from the laboratory and production areas.

6.4.5 Quality control and other refreshment areas shall be independent of production area.

6.4.6 Working and in-process space shall be adequate to permit orderly and logical positioning of equipments.

6.4.7 Pipe-work, electrical fittings, ventilation openings and similar service lines shall be designed, fixed and constructed to avoid creation of recesses.

6.4.8 Service lines shall preferably be identified by colours and the nature of supply and the direction of the supply and the direction of the flow shall be marked / indicated.

6.4.9 In the sterile facility, The manufacturing areas shall be clearly separated into support areas (eg: washing & component preparation areas, storage areas etc.), preparation areas (eg: bulk manufacturing area, non-aseptic blending areas, etc), change areas, and aseptic areas. Light fittings and air grills shall be flushed with walls and not hanging from the ceiling, to prevent contamination. There shall not be any sinks and drains in the Grade A & Grade B areas. Doors shall be made of non-shedding materials, preferably of Aluminium or steel material. Wooden doors shall not be used. Doors shall open towards the high-pressure area so that they close automatically due to air pressure. Materials transfer between aseptic areas and outside through suitable air locks or pass boxes. Change rooms should be given appropriate interlocking system, to prevent opening of more than one door at a time.

6.4.10 The interior surfaces (walls, floor, ceiling) shall be smooth and free from cracks, coved, permit easy cleaning, painting and disinfections.

6.4.11 Facilities should be designed, constructed, and maintained to prevent entry of insects, pests, birds, vermins and rodents.

6.4.12 Adequate lighting should be provided in all areas to facilitate proper operations.

6.5 Drawings should be prepared as per the format enclosed.

6.6 Drawings can be taken printout in A4 or in A3 size paper depends on the requirement.

6.7 Drawing format consists of the following

6.7.1 Direction symbol will be at the top left corner if required, which shows all the four directions East, West, North and South.

6.7.2 Entire drawing shall have a Single line border and drawn to scale.

6.7.3 Legend should be there in all the drawings.

6.7.4 At the bottom right corner, footer is present.

6.7.5 Footer format In the first row of the footer write the Company logo & Name with address. Write the Block name, Floor number and Type of the drawing against the TITLE. Write the No. of the drawing against the DRAWING No. Write the size of scale against the SCALE. Write the sheet number X of Y (X is the sheet number and Y is the total number of sheets) against SHEET. Write the version number against REVISION. Write the names of the persons against DRAWN BY, REVIEWED BY, and APPROVED BY. Write the note points against the NOTE.

6.7.6 Any change in the facility should be through change control.

6.8 Procedure for signing the drawings

 6.8.1 Person who draws the drawings shall sign against DRAWN BY followed by date.

6.8.2 Person, who signs against REVIEWED BY, should review the drawings with for its adequacy.

6.8.3 Head Projects and Head QA will sign against APPROVED BY.

6.8.4 Project department approval ensures that the drawing meets the process requirements.

6.8.5 QA approval ensures that the drawing meets the Regulatory and cGMP requirements.

6.9 Based on the drawings and the defined criteria’s, Room Data Sheets are developed.

6.10 For each room, Room Data Sheet Should be prepared as per the Unique Format No.

6.11 The contents of the Room Data Sheets may vary from room to room and those should be maintained in electronic format.

6.12 Projects & QA department shall approve the Room Data Sheets.

6.13 The construction work starts after the approval of Drawings & the Room Data Sheets developed.

6.14 Construction

6.14.1 Careful supervision should be done during the construction phase to make sure that all the design specifications are being met.

6.14.2 After the construction of the new facility or revamping, it should be qualified through Facility Qualification Protocol.

6.15 Facility Qualification

6.15.1 Facility qualification should be carried out Block wise and also by Room wise.

6.15.2 Facility Qualification Protocol should be prepared Block wise to qualify the facility.

6.15.3 The Facility qualification protocol shall be as detailed as possible to avoid later confusion.

6.15.4 Facility qualification Protocol should be prepared as per the format F02/SOPQA002-00.

6.16 Preparation of Facility Qualification Protocol

6.16.1 Facility Qualification protocol consists of the following and it can be changed as per the requirement. Facility Qualification Protocol is maintained in electronic format. TABLE OF CONTENTS        Protocol Approval

Consists of the Name, Designation, Signature and date of the person(s) responsible for the Preparation, Checking and Approval of the Protocol.        Objective

The objective of the protocol shall be mentioned in this section.        Scope

The scope of the subjected facility shall be mentioned in this section        Execution team

In this section, various responsibilities of different departments involved in the qualification activities shall be mentioned.        Facility Description

Brief description of the Facility shall be mentioned.        Basis of Facility design

The Facility size & other details with reference to user requirement specifications shall be mentioned. Detailed Specifications & Verification of Facility

The facility shall be qualified room wise. Check list is prepared as per the Unique Format No. from Room Data Sheets and the drawings. Each room is qualified using this checklist and annexed.        Summary and conclusion        Design qualification post approval.

Consists of the Name, Designation, Signature and date of the person(s) responsible for the Preparation, Checking and Approval of the Protocol.

6.16     Facility Qualification Protocol –Header

6.16.1 Write the number of the protocol against the PROTOCOL NUMBER.

6.16.2  Write the Protocol implementation date against the EFFECTIVE DATE.

6.16.3 Write the name of the block against the BLOCK.

6.16.4  Write module number against the MODULE.

6.16.5  Write the page number against PAGE No. as given below  Page X of Y (X is the page number and Y is the total number of pages).

6.16.6 Facility Qualification Protocol Numbering

FQ   – FQ for Facility Qualification

/  – Slash

XX –   Department Code

  / – Slash

NN – Sequential number

Typical example: FQ/PA/01 is the first Facility Qualification Protocol of Production Block “A”

7.0 Distribution

8.1 Master copy –           Quality Assurance

8.2 Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, HR.

8.0 History

     Date    Revision Number                       Reason for Revision

                       New SOP



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