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DOCUMENT & DATA CONTROL SYSTEM. Presentation by Asad-uz-zamam , Deputy Plant manager Wilshire Labs. (Pvt) LTD. Quad-E- Azam Industrial Estate, Lahore. DOCUMENT & DATA CONTROL SYSTEM. DOCUMENTATION & RECORDs (PART I) Approved & Controlled Document

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document data control system

DOCUMENT & DATA CONTROL SYSTEM

Presentation by Asad-uz-zamam, Deputy Plant managerWilshire Labs. (Pvt) LTD.Quad-E- Azam Industrial Estate, Lahore

document data control system1

DOCUMENT & DATA CONTROL SYSTEM

DOCUMENTATION & RECORDs (PART I)

Approved & Controlled Document

- We should Follow & write what we did

- We should not deviate from what is written in Document.

Description of the Document

- Specifications and procedures for all materials and methods of manufacture and control.

- Ensures all personnel know what to do and when to do it.

- Ensure that authorized persons have all information necessary for release of product.

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DOCUMENT & DATA CONTROL SYSTEM
  • Good documentation
  • It is an essential part of the quality assurance system and, as such
  • should exist for all aspects of GMP.

ISO GMP Guide lines WHO GMP Guide lines

US-FDA Guide lines ICH Guide lines

UK GMP Guide lines MCC GMP Guide lines,

  • South Africa

TGA GMP Guide lines, Japanese GMP

  • Australia
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DOCUMENT & DATA CONTROL SYSTEM
  • Benefit of the Documentation system
  • -Regular review of documents.
  • Ensures Up to date documents (current)
  • Amended Documents are available.
  • - Superseded documents removed properly and not used.
  • - Properly Distribution & Retrieval of Documents.
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DOCUMENT & DATA CONTROL SYSTEM
  • Why are documents so important?
  • - Communication
  • It’s a means of Communication.
  • - Cost

Due to availability of documents like

Sops/Specification that does not allow

to raise CA/PAs so no there is additional

cost .

  • - Audit /Inspections

Due to availability of documents, it helps

in conducting Audit/inspection in a

better.

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DOCUMENT & DATA CONTROL SYSTEM
  • The Contents of Documents
  • Documents should have unambiguous contents.
  • The title, nature, purpose, Responsibilities, Procedure should be clearly stated.
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DOCUMENT &DATA CONTROL SYSTEM

-They should be laid out in an orderly fashion and be easy to check. - Documents should be clear and legible.

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DOCUMENT & DATA CONTROL SYSTEM
  • Finished Products
  • All finished Products should be identified by labeling, as required by the national legislation, bearing at least the following information:- The name of the Product- A list of the active ingredient(s) showing the amount of each present and a statement of the net contents (e.g. number of dosage units, weight, volume)- The batch number assigned- The Mfg. Date-The expiry Date
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DOCUMENT & DATA CONTROL SYSTEM
  • Reference standards
  • The label and/or accompanying documentshould indicate
  • -Potency or concentration,
  • -Date of manufacturing,
  • -Expiry date,
  • -Date of the closure after it is first opened,
  • - Storage conditions etc.
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DOCUMENT & DATA CONTROL SYSTEM
  • Specifications and testing procedures -Testing procedures described in documents should be validated in the context of available facilities and equipment before they are adopted.-There should be appropriately authorized and dated specification, including tests on identity, content, purity and quality, for starting and packaging materials, In-Process Products and for finished products.
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DOCUMENT & DATA CONTROL SYSTEM

Labels

  • Labels are used for containers, equipment or premises should be clear, unambiguous and in the company’s agreed format.
  • It is often helpful in addition to the wording on the labels to use color to indicate status (e.g. quarantined, accepted, rejected, clean).
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Document & Data Control System

Labels

What must be labelled?

- Containers, equipment, premises

Label information?

- Clear, unambiguous,

- Colours can be used, e.g. green (accepted), red (rejected)

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DOCUMENT & DATA CONTROL SYSTEM

Labels

Different types of labels, e.g. cleaning status, production stage, status of materials,

Recoverable Materials. To be Cleaned etc

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Document & Data Control System

Labels

can indicate the status of materials

such as

"quarantine”, “Rejected”,

“Approved” “Out Of Specification” etc.

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Document & Data Control System

Finished Product Label

That includes:

- Name

- Active ingredients and their amounts

- Batch number

- Expiry date

- Storage conditions, precautions if necessary

- Directions for use,

- Name and address of manufacturer

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Document & Data Control System

Specifications and Test Procedures

Specifications:

- Periodic review.

- Compliance with current pharmacopoeia &

reference standards available.

Test Procedures:

- Validated (facility and equipment) before routinely used

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Document & Data Control SYSTEM

Specifications: Starting and packaging materials

Include:

- Name and internal code

- Pharmacopoeia (if applicable)

- Qualitative and quantitative requirements and

limits

Other data may include:

- Supplier

- Sampling procedure or reference

- Storage conditions, precautions

- Retest date

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Document & Data Control SYSTEM

Sampling of Starting Materials

  • What types of documents are associated with sampling of starting materials?

- “Sampling Procedure”

- “Request for sampling”

- “Sampling Form with description of samples”.

- “Sampled” slip

- “ Approved” or “Rejected” slip

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Document & Data Control System

Master Formula

Master formula for each product and batch size

  • Manufacturing instructions (SMP) that includes:
    • Name of product with product reference code
    • Dosage form, strength and batch size
    • List of starting materials including quantities and unique reference code
    • Expected final yield with acceptable limits
    • Processing location and principal equipment
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Document & Data Control System

Standard Manufacturing Procedure

  • Manufacturing instructions
    • Equipment preparation (e.g. cleaning, assembling, calibrating, etc.)

- Detailed stepwise processing instructions and checks, sequence of additions, times, temperatures, etc.

- In-process control instructions and their limits

- Storage requirements and special precautions

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Document& Data Control System

Batch Manufacturing Records

  • - Name of the product, batch number
  • - Dates and times (e.g. start, major steps, completion)
  • - Name of person responsible for each stage of production
  • - Name of operators carrying out each step (check signatures)
  • - Theoretical quantities for materials in the batch
  • - Reference number and quantity of materials used in the batch
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DOCUMENT &DATA CONTROL SYSTEM
  • Batch Manufacturing Record
  • - Record kept for each batch processed based on the master or specifications (e.g. copied to avoid errors)
  • Check suitability of area and Equipment, clear of previous products, documents, materials.
  • - Checks recorded
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DOCUMENT & DATA CONTROL SYSTEM

Batch Manufacturing Records

  • - Main processing steps and key equipment
  • - In-process controls carried out, person's initials, and results obtained
  • - Yield at each stage with comments on deviations
  • - Expected final yield with acceptable limits
  • - Comments on any deviations from process
  • - Reconciliation of the Product
  • - Area clearance check, instructions to operators
  • - Record of activities
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Document & Data Control System

Master Formulae (Packing Material)

  • Authorized packing instructions for each product, pack size and type, and to include:

-Name of the product

-Dosage form, strength and method of application

-Pack size (number, weight or volume of product in final container)

-List of all packaging materials (quantities, size, types and code number)

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Document & Data Control System

Packing instructions

-Special precautions, including area clearance checks (before and after operations).

-Description of the packaging operation including equipment to be used.

-In-process controls, with sampling instructions and acceptance limits.

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Document & Data Control System

Batch Packaging Records

For every batch or part of a batch

  • Before start – checks that equipment and work station suitable and clean, no previous product
  • Get “Line clearance Certificate” as per Sop.
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Document & Data Control System

Batch Packaging Records

  • Name of the product, batch number and quantity to be packed
  • Batch number, theoretical quantity and actual quantity of finished product
  • Actual quantity obtained
  • Dates and times of operation
  • Name of person responsible for packaging, initials of operators carrying out each step
  • Checks, and in-process results
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DOCUMENT & DATA CONTROL SYSTEM

Batch Packaging Records

- Details of packaging operation, including equipment and line used

- Returns to store

- Specimen of printed packaging materials, with batch coding approval (batch number and expiry date)

- Comments on deviations from the process and actions taken and authorization

- Reconciliation of packaging materials, including issues, use, returns and destruction

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Document & Data Control System

Standard Operating Procedures (SOP)

  • What is an SOP ?
  • Who is responsible for preparing SOPs ?
  • What is the format for an SOP ?
  • Which activities require SOPs ?

- Where should SOPs be stored ?

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Document & Data Control System

Standard Operating Procedures (Sop

Which activities require SOPs?

Equipment and analytical apparatus:

-Assembly - Validation

- Calibration - Internal labelling,

- Quarantine - Storage of materials

- Maintenance/Cleaning - Self Inspection

Personnel Matters

  • Job Description with Qualification
  • -
  • Training
  • Clothing - Hygiene
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Document & Data Control System

Standard Operating Procedures

- Environmental monitoring

- Customers Complaints

  • Product Recalls from the Distributor/Market

- Rejected & Returned goods

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Document & Data Control System

Standard Operating Procedures

  • SOP and records for receiving materials

-Name of material as on delivery note.

-Name and in-house code.

-Date of receipt.

-Supplier's and manufacturer's name.

-Batch number.

-Quantity and number of containers received.

-Status of container and other information.

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DOCUMENT & DATA CONTROL SYSTEM
  • Standard Operating Procedures
  • Batch release or rejection
  • Equipment assembly and validation
  • Maintenance, cleaning and sanitation