Sushant Sardana

Objective

To enhance the level of awareness on the importance of good documentation in making pharmaceutical and health care products

GMP Documentation can be applicable to:Procedure, instruction, logbook, record, raw data, manual, or policy associated with the development, manufacture, testing, marketing, and distribution of a product required to demonstrate compliance with the GMPs and other regulatory requirements.

Egyptian Pyramid Work of art

Expensive

Object of high quality

No information available on how it was created.

Purposes of Documentation

It’s required by LAW!!! Keep track of activities. Create legal documents. Provide a historical record.

Cost for Good DocumentationCost for Poor/No

Documentation

Keep in mind, after the product is distributed to the

customer, what remains with us is documents.

Purposes of Documentation To understand what needs to be done (the process) To understand how to do it (the method) To understand why it needs to be done (the context) To understand who must do it (the responsibility) To understand when to do it (frequency, close out) …. At the end: to ensure that there is an adequate

record of who did what, when, how and why!

Comments at the beginningWhy do people sometimes fail to document activities or events properly?

People don’t understand the legal requirement of documentation. People do not relate records to auditing. People don’t clearly understand what , how or when to document. Procedures may not be completely understood or followed. People aren’t always held accountable. People will make mistakes. People don’t always make corrections properly.

Batch Records are major documents reviewed by regulators

Nine Characteristics of a Quality GMP Record Permanent. Legible Accurate Prompt Clear Consistent Complete Direct Truthful

Good Documentation Practices

Permanent o The information cannot be changed, erased or washed off.o Each time we prepare a Document…….

o Correct ink and color type is used ( no Gel pens/Fountain ink pens)

o Blue ink Ball Point peno Cannot erase the information (no Pencils)

Good Documentation Practices

Legible

o The information can be easily read.o Each time we prepare a Document…….

o Printing and handwriting can be easily read.o Errors are properly corrected with one line through the original

entry, correct entry, initialed and dated. Explained where required…..o Do not erase, overwrite, scribble or “white out” original entries

Clearly Record the Data

What’s that number?Is it 27? 29? 24? 2%Hmmmm. What do we do now?

Good Documentation Practices

Accurate o Calculations are correct and other information is recorded with care.o Each time we prepare a Document…….

o Entries are reviewed and verified by someone elseo Spelling of product names and other words are correct

Good Documentation Practices

Prompt o Information is recorded in a timely way. o Actions are documented immediately after they are performed, never before.o Each time we prepare a Document…….

o Information is recorded immediately as it is obtained -Online Documentation.

o Do not post date or pre-date

Good Documentation Practices

Clear o Everyone who reads the document has the same understanding of what it

means.o Each time we prepare a Document…….

o Just the facts!o Five years from now, someone reading the document will be able to

reliably and easily recreate the event or process.

Good Documentation Practices

Consistent

o All information, such as dates, times, abbreviations etc should be standardized so there is no room for confusion.

o Each time we prepare a Document…….o The proper formats for date and time are usedo Lot code and expiration date are recorded using the correct format

(e.g. Date shall be entered in DD/MM/YYYY format.o Time (A.M. or PM)

Good Documentation Practices

Complete o All required information is included.o Each time we prepare a Document…….

o Blank spaces should be lined out, write “Not Applicable,” initial and date.

o For multiple spaces, one line throughout is acceptable, write “Not Applicable,” initial and date.

o Do not use “ditto” marks or lines with downward arrows.

Good Documentation Practices

Direct o Information is recorded immediately onto the proper form - Batch

Records, Log Book/Sheets, laboratory notebook.o Each time we prepare a Document…….

o The original entry is made into the official wordo No writing on “post its,” “Paper slips” etc.

Good Documentation Practices

Truthful

o All information included in the document is, to the writer’s knowledge, what really happened

o Each time we prepare a Document…….o You take responsibility for your work and what you have written by

Signing (or initialing) and dating the documents.

“ “ I swear to follow the good documentation practice I swear to follow the good documentation practice and document the actual information and on line…..”and document the actual information and on line…..”

Regulatory expectations:FDA Requirements on Batch Production and Control Records

FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES

DRUGS: CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALSBatch production and control records.

Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall

include:(a) An accurate reproduction of the appropriate master production or control record, checked for

accuracy, dated, and signed;(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the

batch was accomplished, including:(1) Dates;

(2) Identity of individual major equipment and lines used;(3) Specific identification of each batch of component or in-process material used;

(4) Weights and measures of components used in the course of processing;(5) In-process and laboratory control results;

(6) Inspection of the packaging and labeling area before and after use;(7) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate

phases of processing;(8) Complete labeling control records, including specimens or copies of all labeling used;

(9) Description of drug product containers and closures;(10) Any sampling performed;

(11) Identification of the persons performing and directly supervising or checking each significant step in the operation, or if a significant step in the operation is performed by automated equipment, the identification of the person checking the significant step performed by the automated equipment.

(12) Any exceptions/investigation for the batch.(13) Results of examinations.

Regulatory expectations: EU-GMP Requirements on Good Documentation Practices

Regulatory expectations: EU-GMP Requirements on Good Documentation Practices

Regulatory expectations: Schedule M

Documentation and Records. - Documentation is an essential part of the Quality assurance system and, as such, shall be related to all aspects Good Manufacturing Practices (GMP). Its aim is to define the specifications for all materials, method of manufacture and control, to ensure that all personnel concerned with manufacture know the information necessary to decide whether or not to release a batch of drug for sale and to provide an audit trail that shall permit investigation of the history of any suspected defective batch.

Good Documentation Practices

Major Errors UOM (unit of Measurement) correction. Decimal correction. Illegible entry corrected to legible entry Smudged entry corrected to clear entry Change in weights/Equipment codes, time/ date Change in temperature / Relative humidity/Pressure differentials Reconciliation of batch In-process parameters recording. Wrong subtraction, addition and multiplication.

In Summary… Documenting your work is just as important as the

information, product, or service you produce. The documents you prepare should allow someone in the

future to reliably, clearly, completely, and easily re-create an activity, event, or process.

The better the documents we produce, the better it is for the users of our products, our organization, and ourselves.

It takes less time and energy to produce a quality document than to deal with frustration. Problems and potential regulatory issues that result from inadequate documentation.

The records you produce must meet the 9 characteristics of a well-made document

If it is not Documented, it Did not Happen

First witness the things yourself then write in document

Write when it happens. Do not write late or all together