Format Content and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

Frederick National Laboratory for

Cancer Research , Frederick , MD

Standard Operating Procedure

Biopharmaceutical Development Program

Title: Format, Content, and Identification of Standard Operating

Procedures

SOP Number:

21400

Supersedes: Revision

Revision Number:

Effective Date:

SEP

13 2018

Table of Contents

1.0 Purpose

2.0 Scope

3.0 Authority and Responsibility

4.0 Procedure

5.0 Definitions

6.0 References and Related Documents

7.0 Attachments

1.0 Purpose

This SOP defines the format, content, and identification system for Standard Operating

Procedures (SOPs) for each department in the Biopharmaceutical Development Program (BOP).

2.0 Scope

This procedure applies to Standard Operating Procedures written for the BOP. For origination,

modification, and control of SOPs, see

SOP 21418

•

Control and Request of

Documents/Records

and

SOP 21419- Origination, Modification, and Approval of

Documents.

This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract

Originator/Date:

Approval/Date:

Page 2 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

3.0 Authority and Responsibility

3.1 The Director, Regulatory Affairs, Biopharmaceutical Quality Assurance (BQA) has the

authority to define this procedure and is responsible for the implementation of this

procedure.

3.2 BQA or designee is responsible for:

3.2.1 Assigning SOP numbers and providing the SOP template (See Attachment 1) to

the originator when they request an SOP number for a new procedure.

3.2.2 Formatting the final SOP before it is routed for signature.

3.3 It is the responsibility of the Manager/Supervisor of each department to ensure that the

SOP is updated/revised on schedule.

3.4 The Director, Biopharmaceutical Quality Assurance, BQA is responsible for quality

oversight of this procedure.

4.0

Procedure

4.1 General SOP Format

4.1.1 Type the content of Standard Operating Procedures in Microsoft Word using Arial

Font, point size 11. Use left justification, and single-line spacing throughout the

SOP. Use complete sentences throughout the SOP, when appropriate.

4.1.2 Tables, Figures, and Diagrams may be incorporated within the body of text. Pages

may be oriented as portrait or landscape and reduced in size to accommodate

tables, figures, and/or diagrams.

4.1.3 BQA or designee will ensure existing SOPs are formatted using the current SOP

template (See Attachment 1) (as they are revised). The SOP/MEF Database auto-

converting “Create Draft” feature can be used to format the SOP before it is sent to

the requestor for revision.

4.1.4 Forms attached to SOPs follow a specific format. The header of the form consists

of the following:

• FNLCR, BDP (first line)

• Form No.: 21145-01 (Example)

• SOP No.: 21145 (Example)

• Revision 00:

• If the form is a revision, the header will have the Revision Number: Revision

01, 02, etc.

4.1.4.1 Forms are inserted into the procedure as “.pdf” files when the SOP is

routed for signature. Forms may be oriented as portrait or landscape as

necessary.

This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract .

Page 3 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

4.1.4.2 Forms shall be uniquely identified with the SOP number immediately

followed by a hyphen and a two-digit number that reflects the form order

following the SOP. For example:

First SOP Form 21403-01;

Second SOP Form 21403-02;

Third SOP Form 21403-03.

4.1.4.3 Forms that are attached to other SOPs may be mentioned in the SOP but

may not be attached. For example, Form 21503-01 could be mentioned

in this SOP but cannot be attached to this SOP. Form references do not

include the revision number.

4.1.4.4 The form revision is the same as that of the SOP. For example, if the

SOP is Revision 01, then the Form is Revision 01.

4.1.4.5 The effective date of the form is the same effective date of the procedure

(SOP). BQA adds the effective date on the form when it is issued (i.e.,

Revision 00: APR 06 2018).

4.1.5 Attachments to SOPs are labeled using numbers; Attachment 1, 2, 3, et cetera.

4.1.6 Identifying SOPs in Word Processing

4.1.6.1 Use the SOP number as the electronic file name. Identify it as “DRAFT”

or “EFFECTIVE”, and the digits of the SOP number including the revision

number. Examples:

• DRAFT SOP 12345, Rev. 00 (While the procedure is in review and

before the procedure is finalized.)

• APPROVED SOP 12345. Rev. 00 (This is an automated step from the

database.) When you make the SOP Effective in the database (10

days from date of final signature) the system marks it approved.

• EFFECTIVE SOP 12345, Rev. 00 (When the procedure is finalized

and posted on the effective date the database changes the file name

to “Effective”)

4.1.7 SOP Paper

4.1.7.1 The original, official master of the SOP is printed on white paper and

contains the handwritten, original signatures in black or blue ink.

4.1.7.2 Controlled copies are printed on blue paper and the control number is

printed on the footer of the controlled copy (that is assigned to an SOP

Manual). Example:

• Control Number: 012345

This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract

Page 4 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

4.1.8 SOP Headers

4.1.8.1 The first line of page one of the SOP contains the name of the

organization and the words “Standard Operating Procedure”.

4.1.8.2 The second line in the first page header contains the title of the SOP.

(Use Font size 14).

4.1.8.3 The third line on the page one header contains the SOP Number and the

revision level. The revision number is 00 for new SOPs and 01 for the

first revision of the document, et cetera.

4.1.8.4 The fourth line in the header is the superseded revision number and the

effective date.

If the document is a new document, type N/A in the Supersedes section.

If the document is being revised, type in Revision 01 if it is replacing

Revision 00, or Revision 02 if it is replacing Revision 01, et cetera. If the

document number was changed, for example from 6002 to 21239, then

use 6002, and Revision 00 in the supersedes section.

4.1.8.5 Signatures are required on the first page only of the SOP.

• The Originator/Date

– BQA or designee ensures that the database

adds the originator’s name, and department (in bold, using pt 8 font);

the originator signs his/her name and date on this line to signify

approval.

• At a minimum, two approval signatures/dates are required in addition

to the originator/author (the approver’s names and titles are typed

under each signature line). This includes the originator’s supervisor

and a Biopharmaceutical Quality Assurance (BQA) signature.

• The originator's supervisor or manager, or system/area owner; or in

some instances, the Supervisor and Manager will sign in the approval

section. For SOPs that affect critical systems in the BDP, the

Program and Technical Director and the Director of BQA signatures

are required.

• Biopharmaceutical Quality Assurance (BQA) reserves the right to

designate additional signatories.

• SOPs that pertain to GxP (GMP, GLP, GCP, etc.) operations,

materials, systems, etc., require BQA review and signature.

4.1.9 General

4.1.9.1 When typing a note in the SOP, type it as follows in BOLD and

Underlined.

NOTE: Do not underline the colon or punctuation (unless the entire

sentence is underlined), except for the last punctuation mark.

The note is separate from the sentence, so it is easily read.

This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract .

Page 5 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

4.1.9.2 Use BOLD and 12-point font when typing the section titles in the SOP.

Example: Authority and Responsibility.

4.1.9.3 Put caution or warning statements in bold.

4.1.9.4 Use capital letters sparingly. Capital letters are harder to read.

4.1.9.5 Use the legal numbering system for SOPs. Use bullets to set off phrases.

4.1.9.6 A single section break must stay on the first page header, so the

second page header will be correct.

4.1.9.7 When a procedure is requested for a revision, a Revision Justification

Form 21419-02, must be included, see Section 6.0 of SOP 21419 -

Origination, Modification and Approval of Documents

4.1.9.8 Procedures that are referenced in the body of an SOP must include the

SOP number and the title each time they are referenced. Referenced

procedures are in BOLD Italics. Example:

• SOP 21419 - Origination, Modification and Approval of

Documents

4.2 General SOP Contents

4.2.1 SOPs shall contain the following sections. Additional sections may be added as

necessary.

4.2.1.1 Title: Write a clear and concise title to allow the reader to identify the

contents of what is included within the SOP.

4.2.1.2 Purpose: State the purpose of the procedure being described. Write the

purpose in complete sentences.

4.2.1.3 Scope (Application): Give the intended personnel, situation, protocol,

location (wing/room number), project (if project specific), etc., to which the

procedure applies. Describe situations where the SOP would not apply.

Example: This SOP applies to BDP Production personnel in the

4.2.1.4 Overview (Optional): The purpose of the overview section is to make the

purpose, application, or use of the SOP easier to understand. It may

include background, historical, or other information. It could also include

information on the criticality of the SOP or certain steps within the SOP.

NOTE: When this section is included in the SOP it will be included in the

Table of Contents.

4.2.1.5 Authority and Responsibility: Briefly list by title and/or department the

individuals and their responsibilities for preparing, managing, using the

SOP, and updating the SOP.

This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract .

Page 6 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

4.2.1.6 Procedure: Provide step-by-step instructions for the procedure. Refer to

other SOPs or literature when appropriate. Write the procedure section at

a level that would allow any reader, who is versed in the general

knowledge to which the SOP pertains, to be able to perform the

procedure and obtain the desired results.

4.2.1.7 Definitions and Abbreviations (Optional): Define any terms used in

the procedure which may be unfamiliar to the user. Keep in mind that

SOPs are also training tools and this section can be explanatory or

educational.

4.2.1.8 Safety Considerations (Optional): If it is appropriate, provide examples

of any safety considerations for the SOP. There are some SOPs that

require approval and signature from the Environmental Health and Safety

Program (EHSP).

4.2.1.9 References and Related Documents (Optional): List any references

such as Code of Federal Regulations, Batch Production Records, or

publications applicable to the document. List referenced SOPs, MPRs,

etc., as applicable to the SOP. Do not list an SOP unless it is mentioned

in the body of the document. Do not include the revision number of the

SOP. Add regulatory references as necessary and the name of

equipment manuals when appropriate.

4.2.1.10 Attachments: Attach tables, examples of forms, technical literature,

diagrams, or any other information which will assist the user in following

the SOP. The use of flow charts and diagrams is encouraged.

• List flow charts and diagrams first then forms associated with the

SOP.

• List the word Attachment and the number in BOLD, followed by the

title of the attachment.

4.2.2 Other sections of the SOP shall be tailored to suit the purpose of the SOP and to

ultimately provide a clear, concise document. The following are some examples of

additional sections.

• Acronyms

• Calculations (calculations must include units)

• Calibration

• Disposition

• Documentation

• Formats

• Safety Data Sheets

• Quality Control

• Reagents

• Required Equipment (with Master Equipment File number)

• BDP Part Numbers

• Required Materials and Documentation

This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract .

Page 7 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

4.3 SOP Identification

4.3.1 Assigning SOP Numbers

4.3.1.1 BQA provides SOP number assignments in accordance with the

categories of procedures as shown in Attachment 2.

4.3.1.2 BQA maintains the SOP/MEF Database for an up-to-date list of BDP

SOPs with the effective dates and maintains master SOP files by

document number.

5.0

Definitions

5.1 Standard Operating Procedure (SOP) – A document that describes a policy, system

and/or routine operation (such as a technical procedure, the use, cleaning and

maintenance of equipment, validation and calibration procedures, or document

preparation).

6.0

References and Related Documents

6.1 SOP 21418 Control and Request of Documents/Records

6.2 SOP 21419 Origination, Modification, and Approval of Documents

6.3 21 CFR 58.81(a): GLP – Testing Facilities Operation

A testing facility shall have standard operating procedures in writing setting forth nonclinical

laboratory study methods that management is satisfied are adequate to ensure the quality

and integrity of the data generated during a study.

6.4 21 CFR 211.100(a): Drugs – Written Procedures

There shall be written procedures for production and process control designed to assure

that the drug products have the identity, strength, quality, and purity they purport or are

represented to possess. These written procedures, including any changes, shall be

drafted, reviewed, and approved by the appropriate organizational units and reviewed and

approved by the quality control unit.

7.0 Attachments

7.1 Attachment 1 SOP Template

7.2 Attachment 2 SOP Numbering System

This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract .

Page 8 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

Frederick National Laboratory for

Cancer

Research

Frederick,

I I I

Biopham1aceutical Development Program

Title:

SOP Numbe r:

Supersedes : Revision

Attachment 1

SOP Template

Standard Operating Procedure

Revision Number :

Eff ecti ve Date:

Page 1 of 2

Origi nato r/Date:

Approval/Date :

Table of Contents

1.0 Purpose

2.0 Scope

3.0

Authority and Responsibility

4.0 Procedure

5.0

References and Related Documents

6.0

Attachments

1.0 Purpose

2.0 Scope

3.0

Author ity and Respons ibility

4.0 Procedure

5.0

References and Related Documents

6.0 Attachments

This procedureis made available through federal funds from the National cancer Institute, NIH, undercontract

This procedure is made available throughfederal fundsfrom the National Cancer Institute, NIH, under contract

Page 9 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

Attachment 1 (Continued)

SOP Templates

FNLCR, BOP

SOP Numbe:r

Titl e:

RevisionNumber: EffectiveDate:

Attachment 1

Page 2 of2

This procedure is made available through fe<leral funds from the National cancer Institute, NIH, under contract

This procedure is made available throughfederal funds from the National Cancer Institute, NIH, under contract

Page 10 of 12

FNLCR, BDP

SOP Number: 21400

Revision Number: 05

EffectiveDate: SEP 13 2018

Title: Format, Content, and Identification of Standard Operating Procedures

UNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY

Attachment 2

SOP Numbering System

Number Series

Department