How to write a standard operating procedure in a Pharmaceutical Industry

 

1.0  OBJECTIVE:

To describe the procedure for Preparation, Review and Approval of standard operating procedure.

2.0  SCOPE:

This describes the basic principles, defines the responsibilities and lays down the procedure for preparing SOPs. This SOP shall be applicable to all the SOPs.

3.0  RESPONSIBILITY:

3.1  Executive/ Officer Q.A/ Designee: Preparation and Revision/ Periodic review of SOPs.

3.2  Q.A Head/ Designee: Review and Training of SOP.

3.3  Site Quality Head/ G.M-works/ Designee: Approval of SOP.

4.0  ACCOUNTABILITY:

4.1  Head of the Q.A Department.

5.0  PROCEDURE:

5.1  All SOPs shall be as per the SOP Format, attached as Annexure-1.

5.2  Each page including Annexure shall bear Company Logo.

5.3  Prepare front cover page of each SOP.

5.4  All the SOPs shall consist of Header, Cover page, Content and Footer part.

5.4.1        The Header Part of each SOP shall remain on first page. The Header part of the SOP shall consist of the following:

5.4.1.1  Logo: The Logo on the left-hand corner of the header with 30mm (L) x 6mm (H).

5.4.1.2  Standard Operating Procedure: STANDARD OPERATING PROCEDUREshall be printed in Font: Times New Roman letters, Font size: 14, Style: Bold, Capital.

5.4.2        The Cover Page of each SOP shall consist of the following:

5.4.2.1  Title: The title of SOP shall be in Font: Times New Roman letters, Font size: 12, Style: Normal, Bold sentence case. It should be self-descriptive.

5.4.2.2  Copy No.: The copy no. shall appear on the page of SOP except Master Copy.

5.4.2.3  Location: The name of location of the plant for which SOP is applicable. Font: Times New Roman letters, Font size: 12, Style: Bold, Regular.

5.4.2.4  Department: The name of the department preparing the SOP shall be in Font: Times New Roman letters, Font size: 12, Style: Bold, Regular.

5.4.2.5  Area: The name of area/ sub-section of the Department shall be mentioned wherever applicable. Font: Times New Roman letters, Font size: 12, Style: Bold, Regular.

5.4.2.6  SOP No.:

5.4.2.6.1        Each SOP shall have a unique numbering system. Once number is allocated to any SOP, the same number shall not be repeated to other SOP.

5.4.2.6.2        SOP Number shall consist of 16 characters.

5.4.2.6.2.1  First two characters ‘XYZ’ denote “XYZ Limited”.

5.4.2.6.2.2  Third character denotes site, e.g. XYZ for XYZ Plant.

5.4.2.6.2.3  Fourth character denotes slash (/).

5.4.2.6.2.4  Fifth and sixth character denotes Department or Section code, e.g. QA for Quality Assurance, PR for Production.

5.4.2.6.2.5  Seventh character denotes slash (/).

5.4.2.6.2.6  Eighth, ninth and tenth characters denote “SOP”.

5.4.2.6.2.7  Eleventh, twelfth & thirteen characters denote serial number of SOP, starting from “001” onwards.

5.4.2.6.2.8  Fourteenth character denotes dash (-).

5.4.2.6.2.9  Last two characters denote Revision No. of SOP.

5.4.2.6.3        e.g. First new SOP of QA shall have SOP number as XYZ/QA/SOP001-00.

5.4.2.7  Supersede: In case of a new SOP, Supersede No. will be nil. If Revision of SOP is done than the previous SOP No. will be written against supersede.

5.4.2.8  Effective date: The effective date is the date from which the SOP shall be effective. Training shall be given to all concerned personnel before effective date of the SOP.

5.4.2.9  Review date: This is the date, before which the SOP shall be reviewed. Every two years from the effective date, SOP shall be reviewed. In case any need arises, SOP shall be reviewed, before the defined review period through a change control procedure.

5.4.2.10    Prepared/ initiated by: Person preparing the SOP from the initiating department, shall sign with the date, in black ink. Designation shall be printed with department mentioned in Annexure-2.

5.4.2.11    Approved by: Head of the initiating department/ designee shall review the SOP and sign with date, in black ink. Designation shall be printed with department mentioned in Annexure-2.

5.4.2.12    Authorized by: Site Quality Head and his designee shall approve all SOPs of Quality Assurance and Quality Control department. Site Quality Head and concerned Department Head shall approve all SOPs of other departments. They will sign with date in blue ink.

5.4.3        The Content Part of the SOP shall contain the following sections:

5.4.3.1  Purpose/ Objective: This section shall describe the justification for the preparation of the SOP and what is expected from it in one sentence or maximum two sentences starting with a letter “To”.

5.4.3.2  Scope: This section shall indicate the applicability of the SOP and also specifies departments, areas, or sections to which this SOP shall be applicable.

5.4.3.3  Responsibility: Write here the designation of the person/ persons who are directly responsible for the operations mentioned in the ‘Objective’ of the SOP.

5.4.3.4  Accountability: Write here the Head of the Department who is accountable for compliance of the SOP.

5.4.3.5  Material and equipment: Write here the material and equipment used in the procedure, mostly in Production and Q.C SOPs preparation there is need of material and equipment heading.

5.4.3.6  Procedure:

5.4.3.6.1        Write the procedure/ method in short sentences. Do not write the instructions in long paragraphs.

5.4.3.6.2        This section shall cover stepwise activities performed and conditions/ precautions required for implementing the SOP.

5.4.3.6.3        Mention all the checks to be carried out, records to be maintained, frequency of various operations, checks and special precautions, if any.

5.4.3.6.4        SOP text shall be written in simple and clear language in Font: Times New Roman letters, Font size: 12 and space between the lines shall be 1.5 lines.

5.4.3.6.5        A-4 size white paper shall be used for printing.

5.4.3.6.6        Bold letters shall be used for heading or sub-heading.

5.4.3.6.7        All SOP shall be written in English language.

5.4.3.7  Revision Log: It has the following details:

5.4.3.7.1        Revision No.: Revision No. consists of two numerical characters which start from ‘00’ with increment in one digit after each revision. ‘00’ indicates the first issuance of that particular SOP.

5.4.3.7.2        Effective date: It shall be stamped by Q.A. after final authorization before circulating the SOPs.

5.4.3.7.3        Reason: If there will be a change required in the SOP the reason should be given in this column for change.

5.4.3.8  Reference: Mention a list of references or any other guidance documents based on which the SOP has been prepared. If there is no reference for the SOP, mention ‘Not Applicable’ under this sub-heading.

5.4.3.9  Annexure:

5.4.3.9.1        Annexure shall be formats, used for recording the data, related to the activity.

5.4.3.9.2        Mention a list of all Annexure enclosed in the SOP. If there is no Annexure in the SOP, mention ‘Not Applicable’ under this sub-heading.

5.4.3.9.3        Annexure shall have a unique format number linked to the relevant SOP and shall be written at the bottom, left of the page.

5.4.3.9.4        Copy of an Additional Format taken from other SOPs shall be attached as Annexure, which has a linkage or bearing on the said SOP. The same shall be indicated in the list of Annexure.

5.4.3.10    Abbreviations: Mention a list of all abbreviations & their full forms/ descriptions used in the SOP. If there is no Abbreviation in the SOP, mention ‘Not Applicable’ under this sub-heading.

5.4.4        The Footer Part of the SOP shall contain the following sections:

5.4.4.1  Block for stamping purpose: This space shall be used for putting stamp for controlled documents on the photocopies. This block shall be on the right side of the footer.

5.4.4.2  Page No.: The page no. shall appear on the right hand corner of the footer. This specifies the page no., with respect to the total number of pages of the SOP, may exclude the Annexure.

5.4.4.3  Format No.:

5.4.4.3.1        The format number used for preparing the SOP is mentioned in the footer block. Font: Times New Roman letters, Font size: 10, Style: Regular.

5.4.4.3.2        The Format Number shall consist of total 16 characters and this shall appear on all the SOPs.

5.4.4.3.2.1  First two characters ‘XX’ denote Company name.

5.4.4.3.2.2  The third character ‘B’ denotes the manufacturing site.

5.4.4.3.2.3  Fourth character represent “Slash” (/).

5.4.4.3.2.4  Fifth & sixth characters denote the name of the Department or Section.

5.4.4.3.2.5  Seventh, eighth & ninth characters denote SOP no. of respective department to which the format is linked.

5.4.4.3.2.6  Tenth character is “Slash” (/).

5.4.4.3.2.7  Eleventh Character is ‘F’, which stands for format.

5.4.4.3.2.8  Twelfth & thirteen characters represent sequential number to format, starting with ‘00’ onwards.

5.4.4.3.2.9  Fourteenth character denotes dash (-).

5.4.4.3.2.10    Fifteenth & sixteenth characters represent Revision number of the format. If a format is made for the first time it is indicated as “00” in the Revision No. and subsequent revisions in the format shall be indicated by “01”, “02”, and so on.

5.4.4.3.2.11    e.g. XYZ/QA001/F01-00

Where, “XYZ” represents XYZ plant, “QA” represents the Quality Assurance, “001” is the SOP number to which the format is linked, “F” represents the format, “01” represents the format no., followed by dash (-) and “00” indicates the revision number i.e. new format.

5.5  User department shall prepare the draft SOP as per the procedure described in 5.4. Draft copy shall be identified by stamping or watermark on each page.

5.6  Draft copy shall be circulated to responsible persons for its review.

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: SOP Format.

Annexure 2: List of Codes for Site and Department.

 

 

 

 

 

 

 

 

 

 

 

Annexure: 1

SOP Format

STANDARD OPERATING PROCEDURE

TITLE: (detailed title)

SOP No.             :

Supersede           : (in case of new SOP supersede no. will be nil)

Effective Date      :

Review Date        :

Copy No.             : (mention on all pages of SOPs except master copy)

Location       :

Department  :

Area               :

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Initiated By

Approved By

Authorized By

 

 

Name:

 

 

 

 

 

 

 

Signature:

 

 

 

 

 

 

 

 

Date:

 

 

 

 

 

 

 

Department:

 

 

 

 

 

 

 

 

 

 

 

 

 

Format No.:                                                                                                                                                                                                                      SIGN AND STAMP

 

Page 1 of 2

 

STANDARD OPERATING PROCEDURE

1.0       OBJECTIVE:

2.0       SCOPE:

3.0       RESPONSIBILITY:

4.0       ACCOUNTABILITY:

5.0       MATERIAL AND EQUIPMENT:

6.0       PROCEDURE:

7.0       REVISION LOG:

Revision No.

Effective Date

Reason

 

 

 

8.0       REFERENCES:

9.0       ANNEXURES:

Annexure 1:

Annexure 2:         …………. So on.

10.0     ABBREVIATIONS:

Abbreviation

Expanded Form

SOP

Standard operating procedure

&

And

No.

Number 

Ltd.

Limited

COMPANY NAME FIRST ALPHABET

Company Name

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Format No.:

 

 

 

 

SIGN AND STAMP

 

Page 2 of 2

 

Annexure: 2

List of Codes for Site and Department.

Site

Code

Company Name Pharma, Ltd.

COMPANY NAME FIRST ALPHABET

 

DEPARTMENT FUNCTION

DEPARTMENT CODE

Administration

AD

Accounts

AC

Human Resource and Management

HR

Information Technology

IT

Stores/ warehouse

S

Store (Raw material)

SR

Store (Raw Material Quarantine Area)

SRQ

Store (Raw Material Rejected Area)

SRR

Store (Raw Material Sampling Area)

SRS

Store (Raw Material Dispensing Area)

SRD

Store (Raw Material Cold Room)

SRC

Store (Packing Material)

SP

Store (Packing Material Quarantine Area)

SPQ

Store (Packing Material Rejected Area)

SPR

Store (Finished Goods)

SFG

Store (Finished Goods Quarantine Area)

SFGQ

Quality Control

QC

Quality Control (Laboratory)

QCL

Quality Control (Instrument Lab)

QCI

Quality Control (Stability Chamber)

QCS

Quality Control (Retaining Sample Area)

QCRs

Quality Control (Active Ingredients)

QCA

Quality Control (Reagents)

QCR

Quality Control (Equipments)

QCE

Quality Control (Equipment Cleaning)

QCEC

Quality Control (Equipment Operations)

QCEO

Quality Control (Equipment Calibrations)

QCEB

Quality Control (Test)

QCT

Quality Control (in-process test)

QCi

Quality Control (finished product test)

QCf

Quality Control (Finished goods)

QCF

Quality Assurance

QA

Research and Development

R&D

Production

PR

Production (Machinery)

PM

Production (Machinery Cleaning)

PMC

Production (Machinery Operations)

PMO

Production (Machinery Calibrations)

PMB

Production (Methods)

PRM

Production (Tablet)

PT

Production (Capsule)

PC

Production (Sachet)

PS

Production (Syrups)

PL

Engineering

EN

Marketing

MK

Purchase

PU

 

 

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

SOP

Standard operating procedure

&

And

No.

Number  

Ltd.

Limited

Q.A

Quality assurance

G.M

General Manager

L

Length

H

Height

Q.C

Quality control

PR

Production

F

Format

COMPANY NAME FIRST ALPHABET

Company Name

 


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