Croda Inc Procedure Document
TITLE: «dcDocumentsDocumentTitle»
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«dcDocumentRevisionsCurrentViewRevisionNu»
Revision No.:
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1.0 PURPOSE
To outline the proper way to fill out documents and forms which have a direct bearing on the
safety and quality of the product, as required by the International Pharmaceutical Excipients
Council (IPEC), the European Federation of Cosmetic Ingredients (EFfCI) and the International
Standardization Organization (ISO) Standards.
2.0 SCOPE
All Quality documents and recorded information relating to the batch history of products
manufactured at any Croda Inc. facility.
3.0 REFERENCE :
3.1 IPEC/PQG GMP guidelines
3.2 EFfCI GMP guidelines
3.3 ISO 9001:2008
3.4 Croda Quality Manual
3.5 GP-002: Croda GMP Outlines
4.0 DEFINITIONS
4.1 Quality Manual – A company document that describes, in paragraph form, the regulations
and/or parts of the regulations that the company is required to follow.
4.2 Batch Records – Documentation that provides a history of the manufacture of a batch of
excipient.
4.3 Test Methods – These documents are typically used and completed by the Quality
Department.
4.4 Specifications – A list of tests, references to analytical procedures and appropriate acceptance
criteria that are numerical limits, ranges or other criteria for the tests described for a material.
4.5 Logbooks – Bound collection of forms used to document activities.
Typically logbooks are used for documenting the operation, maintenance, and calibration of a
piece of equipment.
4.6 cGMP – Current Good Manufacturing Procedures
4.7 SOP – Standard Operating Procedure.
4.8 IPEC: International Pharmaceutical Excipient Council
4.9 EFfCI: European Federation for Cosmetic Ingredient
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When printed, this document becomes an uncontrolled copy and will expire 72 hours from the time shown
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Croda Inc Procedure Document
TITLE: «dcDocumentsDocumentTitle»
Document No.: «dcDocumentsDocumentNumber»
«dcDocumentRevisionsCurrentViewRevisionNu»
Revision No.:
Reason for Revision: «dcDocumentRevisionsCurrentViewReason»
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«dcDocumentsDocumentOwner»
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5.0 PROCEDURE:
There are many different reasons for creating and maintaining GMP documentation. Such documents are
required for one or more of the following reasons:
- Keep track of activities
- Create legal documents
- Provide historical records
- Provide crucial information
- Comply with regulations
Everyone on site is responsible for creating Quality Records. These include, but are not limited to
production batch sheets, calibration Records, Maintenance Records, Equipment Log Books, Inspection
Instruction and Results Record (LAB), Good Receipts Notes, Lab Notebooks.
5.1
Entry of data and information
Some of the characteristics of good records are:
Permanent
Accurate
Legible
Prompt (written in a timely matter following the task completion)
Clear (so anyone can read and understand what it meant)
Consistent
Complete
Direct
Truthful
5.1.1 All recorded information relevant to the batch history of a product must only be made on
controlled documents, logbooks and workbooks. All records created could be reviewed or
even be used as evidence in court so they need to be complete, accurate and legible.
The recording of information on scrap pieces of paper is not permitted.
5.1.2
Documents including Logbooks and Workbooks that require data or any other information
to be entered manually must be designed in a way that allows:
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When printed, this document becomes an uncontrolled copy and will expire 72 hours from the time shown
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Croda Inc Procedure Document
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Sufficient space for the entry.
Adequate spacing between entries.
A clear indication of what is to be entered.
5.1.3
No part of a document that requires information or data should be left blank.
If no entry is required and if the field is not applicable to the task performed, then “N/A”
must be written in the space provided. EXCLUSION: Mill Hall batch record.
Important note: If a specific area of a document or a form ceased to be used, the document
owner should be contacted so the document can be updated following current practices in
our controlled document system.
5.1.4
Hand written entries must be made mainly using permanent ink unless otherwise stated in
a controlled document (Pencil is permitted only on sample tag in Atlas Point, red ink pen
is recommended in Mill Hall for subsequent entries )
Hand written information must be clearly legible.
No overwriting is permitted. Corrections to errors should be made following the
instructions in step 5.2 of this procedure.
5.1.5
Signatures/ Initials on a document represents that the task has been performed in
accordance with requirements documented in a controlled documents and any deviations
have been recorded.
Signatures/Initials on a document must be entered in a timely matter after completion of
the task.
Be consistent with date and time.
Never pre-date or pre-complete forms.Backdating any document is considered fraud.
5.1.6
Only controlled documents can be used when recording any data related to the batch.
All controlled documents are available in Intelex or printed out of SAP.
5.2
5.2.1
Corrections
No handwritten changes or corrections will be made to the printed text of an
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When printed, this document becomes an uncontrolled copy and will expire 72 hours from the time shown
in the lower left corner of the document, unless otherwise stamped by Document Control.
Croda Inc Procedure Document
TITLE: «dcDocumentsDocumentTitle»
Document No.: «dcDocumentsDocumentNumber»
«dcDocumentRevisionsCurrentViewRevisionNu»
Revision No.:
Reason for Revision: «dcDocumentRevisionsCurrentViewReason»
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approved controlled document. Consult with your supervisor if you discover an error.
Any changes required to approved documents shall be implemented through the
established controlled document system.
5.2.2
Any corrections made to a document must be initialed, signed and dated by the person
making the change. The correction must permit the reading of the original information.
5.2.3
The use of correction tape, fluid or “Liquid Paper” is not permitted for correcting
errors or for any other reason. The use of erasers is also prohibited.
5.2.4
The following instructions are to be followed when making corrections to any records,
Log Recordkeeping Notebook, Batch Records, and Supervisory Notes to be compliant
with Good Documentation Practices rules.
-Place a single line through the incorrect entry
-Initial and date the adjacent to the cross-out
-Enter the correct data near the original entry
-The mistake must still be legible through the cross-out.
-Date of the correction is the date the correction was made, not the date the error
was made.
- Recommended to add a short explanation about the mistake.
-Complete the record as close to the time you carried out the task as possible;
Important:
- Don’t leave it until the end of the shift to complete multiple sections together.
- If something is added to a record at a later date, this should be clearly presented
by signing and dating with a reason given; do not deface quality records.
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When printed, this document becomes an uncontrolled copy and will expire 72 hours from the time shown
in the lower left corner of the document, unless otherwise stamped by Document Control.
Croda Inc Procedure Document
TITLE: «dcDocumentsDocumentTitle»
Document No.: «dcDocumentsDocumentNumber»
«dcDocumentRevisionsCurrentViewRevisionNu»
Revision No.:
Reason for Revision: «dcDocumentRevisionsCurrentViewReason»
Location: «dcDocumentsTypeID»
«dcDocumentsDocumentOwner»
Department: «dcDocumentsFolderID»
Release Date: «dcDocumentRevisionsCurrentViewReleaseDat»
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Documentation rules for cGMP documents and other critical documents and forms.
The Do’s and Don’ts
When writing/correcting in cGMP
documents DO:
 Always use a permanent pen unless
otherwise indicated in a controlled
document
 Make all entries neat and legible
(readable)
 Initial and date all entries (unless a
signature is required)
 Document each step before moving to
the next
 Use N/A in spaces if it is not fill.
 Record numbers less than one with a
zero before the decimal point.
 Clearly lay out any calculations so
they can be easily checked and
repeated.
 Record the actual time the task was
carried out when it is required to
record the time
 Record raw data directly onto the
record.
 When correcting a document, cross
the mistake with single line, initial,
date.
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When writing/correcting in cGMP
documents DO NOT:
 Use colored ink or pencil (with the
exception of pencil for ATP lab retain
sample tag and red ink pen for MHL
subsequent entries)
 Overwrite
 Use correction tape, fluid or liquid
paper
 Backdate
 Record data before the action or event
has occurred
 Leave required spaces blank
 Approve, verify, or review your own
performance
 Use “ditto” marks and unusual
abbreviations.
 Do not write raw data somewhere else
first and transfer it to the record later.
This can lead to transcription errors or
forgetting to make the record.
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When printed, this document becomes an uncontrolled copy and will expire 72 hours from the time shown
in the lower left corner of the document, unless otherwise stamped by Document Control.