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14 views

Documentation

Uploaded by

abanoub melek
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Documentation

Why Documentation is Important:

1-The main objective of documentation system utilized must be to establish, control, monitor and record all
activities which directly or indirectly impact the quality of products.

2- Documentation provides both:

2.1 Information on when, where, who, why and how to complete tasks in a form of procedures or work
instruction
2.2. Evidence proving that the tasks have been completed and complies with related instructions
(records/reports)
2.3. Provides background history by keeping the information to be a reference for the future and it is a mean
information communication to others specially to ensure that the information will not be lost when
the employee leaves.

Types of GMP Documentation


1- Site Master File: A document describing the GMP related activities of the manufacturer, which include list
of products , List of machines , list of lab instruments, list of contractors , layout of plant
and production flow process.
2- Procedural, Work Instructions or Requirements type:
2.1 Specifications: Describe in detail the requirements with which the products or materials used or
obtained during manufacture have to conform. They serve as a basis for quality
evaluation.
2.2 Manufacturing Formulae: Provide detail all the starting materials, equipment and computerized systems
(if any) to be used and specify all processing, packaging, sampling and
testing instructions. In-process controls and process analytical technologies
to be employed should be specified where relevant, together with acceptance
criteria.
2.3 Processing, Packaging and testing instructions.
2.4 SOPs (Give instruction for performing certain operations)
2.5 Protocols (Give instructions for performing and recording a certain operation)
2.6 Technical agreements: Are agreed between contract givers and acceptors for outsourced activities.
3- Record/Report Type:
3.1 Records: provide evidence of various actions taked to demonstrate compliance with instruction.
3.2 Certificate of analysis: provides a summary of testing results on samples of product or material together
with the evaluation for compliance to stated specifications.
Good Documentation Practices
Documents:

1- Documents should be designed, prepared, reviewed, and distributed with care in a defined system.
2- Documents containing instructions should be approved, signed and dated by authorized persons.
3-Documents should have unambiguous contents and be uniquely identifiable. The effective date should be
defined. (One week after issuing)
4- Standard Operating Procedures, Work Instructions and Methods should be written in imperative mandatory
style.
5- The style and language of documents should fit with their intended use.
6- All documents should use words that every one can understand, reduce using of abbreviations, prefer to use
tables and diagrams.
7- GMP documents should have page numbers using the following standard X of Y to indicate the total
number of document pages.
6- Documents within the Quality Management System should be regularly reviewed and kept up-to-date
(Every two years).

7- Documents are maintained in the same place it was issued.


8-Documents within Management System should be regularly reviewed and kept up-to-date (every two
years). (Change Control System, cancelling – distribution)

Records:

1- Records require the entry of data, sufficient space should be provided for such entries.
2 All fields on a record should have an entry, even if it is N/A., don’t use ditto (") mark to indicate the same
entry as above.
3- Multiple blank spaces/raw/columns on a record must be marked out with a single line across the whole
field; this ensures that the record cannot be added to at a later date without appropriate checking or
approval. Use N/A above the line and sign, date to show that the space is not applicable.
4- If correction needs to be made, make single line through the error- never use correction fluid then record
the correction, record the initials and date.
5- In general, if a decimal value is a fraction of 1 then a zero must be placed before the decimal point.
e.g 0.98 not .98, the number of decimal places to be recorded should be outline in a procedure
e.g when the spec. limit is 2.55 –2.85 and the result is 2.7, then the result recorded as 2.70 not 2.7.
6- Date and time format must be recorded as following in the country as d/m/y (Australia) or m/d/y (USA),
Because of difference between countries; it is recommended that the month is denoted by its first 3 letters
for clarity e.g 11/3/12 or 11/3/2012 or 11 Mar 2012, especially for multi-national companies
7- Record the time in 24 hour format or denoting am. or pm.
8- Handwritten signatures must be unique to the individual and listed within the site signature list, staff are not
permitted to sign for another member unless delegated. Signature list should be routinely reviewed so that
it remains current. New staff should sign the signature register during induction and must indicate the date
staffs exit the company.
9- In the event that a critical member of staff is absent for a time, they must delegate responsibility to another
qualified person. This delegation must be documented with names of a people involved and signed by the
person that is delegating his responsibility.
10- Documents and records should be reviewed by someone who didn’t perform the task to ensure that the
information is correct and accurate, a signature and date by reviewer/approver confirms that a review has
taken place. e.g (Doer and Checker).
11- Back dating of entries is not permitted.
12- Don’t discard a page of a record just because the fields are not applicable because this page could be
mistaken as missing.
13- Logbooks should be kept for major or critical analytical testing, production equipment and areas where
product has been processed. They should be used to record in chronological order, as appropriate, any use
of the area, equipment/method, calibrations, maintenance, cleaning or repair operations, including the
dates and identity of people who carried these operations out.
14- Records are maintained in the same place it was issued.

Retention of Documents:
1- It should be clearly defined which record is related to each manufacturing activity and where this record is
located. Secure controls must be in place to ensure the integrity of the record throughout the retention
period and validated where appropriate.
2- Specific requirements apply to batch documentation which must be kept for one year after expiry of the
batch to which it relates or at least five years after certification of the batch by the Qualified Person,
whichever is the longer.
3- For other types of documentation, the retention period will depend on the business activity which the
documentation supports.

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