Format of SOPs and Forms

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1.0 Purpose 
 The purpose of this procedure is 10 provide guidelines for the preferred format of SOPs and the
 
 20 Seope 
 
 This procedure is applicable te controlled documents intended to meet quality and regulatory
 
 3.0 Responsibility 
 
 itis the responsibility of Quality and DCto implement and maintain this procedure.
 : 
 _ 
 3.2 Ht is the responsibility of all employees to follow this procedure when creating or
 
 4.0 Definitions 
 
 4.4 Cx’ - Change Contral 
 
 42 DC — Document Contro} 
 
 4.3 SOP — Standard Operating Procedure 
 
 Ad WY — Work Instruction 
 
 $5 dA —Job Aide 
 
 4 BPR — Batch Production Record 
 
 
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 NO Rn te ee een

[SOP C-101 | Page 2 of 10]

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 Standard Operating Procedure 
 Format of SOPs and Forms 
 A? TOC — Table of Contents 
 S00 References 
 
 §.1 C-S01, SOP, Document Control Procedure 
 
 6.0 SOP Identification System 
 
 G1 The SOP identification sysiem is made up of two fields: 
 
 6.1.1 Field one consists of a capital letter(s}, which denotes the department that the
 SOP pertains to, 
 
 aen 
 a 
 oL tw teyeoR nitae 
 ast 
 .eB 
 A 
 tno 
 A— General and Personnel: Applies to all departments/personnel at lon
 B ~ Manufacturing: Pertains to the manufacturing of products from
 compounding through packaging/labeling, inclading equipment
 D ~ Laboratory Operations and Specifications, including equipment
 procedures 
 C — Equipment 
 H— Audits 
 two consists of three or four mumbers hased upon functions within
 departments and are numbered sequentially by carcgory/units of 100.
 

[SOP C-101 | Page 3 of 10]

 Standard Operating Procedure | SOP Ne 
 
 Format of SOPs and Forms | me enuy de eos 
 
 « C100 General 
 
 C200 [vestigations 
 
 D-1000 Methods 
 
 6.1.2.1 Individual SOPs are given a sequential number in their appropriate
 
 department and category. 
 
 Nete: SOPs specific to drug products will be identified with a decimal
 
 Example:C-100.0 General 
 
 C-200.0 Investigations 
 
 6.2 Forms are rombered ty the SOP mumber, followed by the capital letter F, and a
 
 consecutive number dependisg upon the number of forms attached to the SOP (e.g.
 wr TQT-PT, C-1O1-P2, C-101-P3, eto}. 
 
 Note: Additional step-by-step instructions (Le. job aides} may be created and
 
 reviewed/approved by departmental Supervisors/Managers to supplement SOPs and
 will be controlled by Document Control. ‘These job aids will not replace existing SOPs.
 
 6.3 Job Aides are numbered by the SOP number, followed by Sapital J#A and a consecutive
 number, depending upon the number of job aides attached to theSOP (e.g, C-101-1A1,
 
 C-1OI-LA2, C-101-1A3, etc} 
 
 S64 Documents wilble evaluated and assigned by Quality. 
 
 6.5 DC will maintain a Table of Contents for SOPs, Job Aides and a Table of Contents for
 Forms, These TOC will reference all current effective revisions of SOPs, job aides, and
 
 forms, along with the effective/review date and associated change control number.
 
 65.1 The TOCs will be updated cach time an SOP, job aide, or form has been revised
 
 
 

[SOP C-101 | Page 4 of 10]

 i 
 Standard Operating Procedure SOP No || Rev Page |4 of 
 Format of SOPs and Forms Cin 8 10 
 
 7.0 Preferred Formatting of SOPs 
 
 74 
 
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 The document header will contain the following information: 
 7414 HBI lonLabsLogo 
 74.2 Document Title 
 arA 
 ® 
 twah taa77 Document Type (SOP, Method, etc.) 
 « 
 Document Identification Number a eh 
 Revision Level }~ 
 » 
 ssC> 
 7.16 Etfective Date 
 dam 3 3“ oS nif eo =oj o 
 Times New Roman font is to be used, 1Qpt or larger. Headers are to be I4pt bold
 fencluding “Standard Operating Procedure’) or larger. 
 There is 1o be | Spt spacing alter paragraphs. 
 document is intended to be hole-punched, which should have at least a .75 lef-hand
 marein. 
 The footer will contain a Confidential and/or Proprietary information statement in
 TunesNew Rornan[0 Bold. 
 Additional sections may beadded as needed to define process requirements.
 “fPeostt meattihyogyd bse maWayy Ginneclliuaddae seemacnttsi onrss f£;o r matateorripaylbes tteo ipenecll ude t; ooli;ng, consumables, or
 Hems required to perform the work, as well as process parameters, 
 

[SOP C-101 | Page 5 of 10]

 Standard Operating Procedure | SOP No | Rev 
 
 Format of SOPsand Forms | C-101 a 10 
 
 Preferred Content for Procedures (refer to Attachment | ~ SOP Template)
 
 81 Purpose: What is the purpose of the procedure?’ What regulation or upper-levei
 Xd 
 proceduresdo the requirements satisty? 
 
 Examine: To define the requirements for hygienic practices to meet 21 ChR Part
 
 oh Scope: What department or process does the procedure cover’? 
 
 Bxantple: AH procedures 
 
 8.5 Responsibility: Who is responsible forthe maintenance of the procedure? Who is
 responsible forthe performance of the procedure? 
 
 Example: Document initiators arc responsible for ensuring that the document is clear,
 concise, and complete using the standard format. 
 
 $4 References: Documents that explain more about the work, or forms to record the work.
 
 example: C-403-P1, Change Control Request Porm 
 to 
 
 8.5 Detinitions: Clarify terms such as acronyms, technical terminology, or regulatory
 
 8.6 Procedure: Requirements to befollowed to accomplish an operation or task, in the order
 ihe steps are performed, when applicable. Flow diagrams should be used whenever
 
 possible. 
 
 8.7 Records: Requirements for record maintenance location and retention times when
 
 8.8 Document Revision History: Includesrevision level, daie, change control number, and
 name ofthe person making the change. 
 
 BO Adtachments: If applicable, any related documents. 
 
 CONFEDENTIAL: For WBE fon Labs use only 
 

[SOP C-101 | Page 6 of 10]

 | Standard OperatingZ FPirre ocedure SOP No | Rey | Page Gat 
 
 9.6 Preferred Content for Forms (refer to Attachment 2 ~ Form Template) 
 
 HBT Jon Labs iago 
 
 O13 ChangeContral Number 
 
 9,2 The body will contain tables and borders. Use the Forms toolbar when possible, te
 allow for electronic entry. 
 
 93 Font size will be sufficient for accurate interpretation by the user,
 
 4 Fieldsfor recording data will be Jaree enough to accommodate data entry as well as
 
 room for carrecting errors. 
 
 2.5 The footer will contain a Confidential and/or Proprietary information statement in
 
 7.6 ‘The footer will contain a Page Number entry box or number of“pages attached to the
 
 Note: Page numbering may also be placed in the header of forms if the content and formatting
 requirements pustify this, 
 
 Niee t$ee: ePeorr mso mpaey be cpeanr ecaray tteeed nieen Portrait or Landse ape mode as needed to provide adeauate
 space for recording information. 
 
 10.0 Attachments 
 10.1 Attachmen1t —~SOP Tesmplate 
 
 10.2 Attachment 2— Porm Template 
 10.3oy Atgtir.a oce h;. mieme nta 3 — J% ob Aj* de ryTtom plate 
 
 
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[SOP C-101 | Page 7 of 10]

 Standard Operating Procedure SOP No Rev | Page 7 of 
 Format of SOPs and Forms cpt S ig 
 }; 
 
 11.0 Revision History 
 
 Revision CCR # 
 0 O2/10/10 - - 
 “ORT TAG - : 
 
 O1/24/14 [4-008 L.. Derrick _ 
 e| 
 ga 
 aah 
 eB 
 t 
 etit 14-0607 O. Pops 
 15-0296 D. Popp AE 
 nm K.. Borris 
 eH 
 )a L1/i2/25 
 AS Bb xed oe 
 
 
 

[SOP C-101 | Page 8 of 10]

 Standard Operating Procedure | SOP No Rey Page 8 of 
 Format of SOPs and Forms ;, C101 i} 18 
 
 ATTACHMENT 1- SOP TEMPLATE 
 
 24 Reape 
 
 3 Responsibility 
 4.0 Defindtions 
 
 &8 Proredwre 
 3.8 Revisios History 
 
 
 

[SOP C-101 | Page 9 of 10]

 3 Standard Operating Procedure / SOP No | Rev age 9 of
 | Format of SOPs and Forms | C10] 3 aD 
 
 ATTACHMENT 2~ FORM TEMPLATE 
 
 NEE . as Date 
 
 
 

[SOP C-101 | Page 10 of 10]

 Standard Operating Procedure SOP Neo Rey | Page il of 
 C-101 $ 
 Format of SOPs and Forms 
 
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