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Packaging Instruction
Formally authorized packaging instruction should exist for each product. Pack size and type. These should normally include, or make reference to:
(a)                The name of the product.
(b)               A description of its pharmaceutical form, strength and, where applicable, method of application.
(c)                The pack size expressed in terms of the number. Weight or volume of the product in the final container.
(d)               A complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types, with the code or reference number relating to the specifications for each packaging material.
(e)                Where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked.
(f)                Special precautions to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations.
(g)               A description of the packaging operations, including any significant subsidiary operations, and equipment to be used.
(h)               Details of in-process controls with instructions for sampling and acceptance limits.

Batch Processing Record
·         A batch processing record should be kept for each batch processed. It should be based on the relevant parts of the currently approved master formulae & processing instruction. The method of preparation of such records should be designed to avoid errors the record should carry the number of batch being manufactured.

·         Before any processing begins, a check should be made that the equipment and work stations are clear or previous products, documents, of materials not required for the planned process, and that the equipment is clean and suitable for use. The check should be recorded.

·         During processing, the following information should be recorded at the time each action is taken. And after completion the record should be dated and signed by the person responsible for the processing operations.
a)      The name of the product.
b)      The number of the batch being manufactured.
c)      Dates and times of commencement, of  significant intermediate stages, and of completion of production.
d)     The name of the person responsible for each stage of production.
e)      The initials of the operator (s) of different significant intermediate stages, and of completion of production.
f)       The batch number and/or analytical control number and the quantity of each starting material actually weighted (including the batch number and amount of any recovered or reprocessed material added).
g)      Any relevant processing operation or event and the major equipment used.
h)      The in-process controls performed. The initials of the person (s) carrying them out, and the result obtained.
i)        The amount of product obtained at different and pertinent stages of manufacture (yield) together with comments or explanations for significant deviations from the expected yield.
j)        Notes on special problems including details, with signed authorization for any deviation from the master formula & processing instruction

Batch Packaging Records
A batch packaging record should be kept for each batch or part batch processed. It should be based on the relevant part of the approved packaging instructions, and the method of preparing such record should be designed to avoid errors. Transcribing from approved documents should be avoided.

Before any packaging operation begins, checks should be made that the equipment and work station are clear of previous products, documents or materials not required for the planned packaging operations, and that equipment is clean and suitable for use. These checks should be recorded.

The following information should be recorded at the time each action is taken, and the date and the person responsible should be clearly identified by signature or electronic password.

a)      The name of the product, the batch number and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained, the quantity actually obtained and the reconciliation.

b)      The date (s) and time (s) of the packaging operations

c)      The name of the responsible person carrying out the packaging operation.

d)     The initials of the operators of the different signification steps.

e)      The checks made for identity and conformity with the packaging instructions, including the results of in-process controls.

f)       Details of the packaging operations carried out, including references to equipment and the packaging lines used, and, when necessary, the instructions for keeping the product unpacked or a record of returning product that has not been packaged to the storage area.

g)      Whenever possible, samples of the printed packaging materials used, including specimens bearing the approval for the printing of and regular check ( where appropriate) of the batch number expiry date, and any additional overprinting.

h)      Notes on any special problem, including details of any deviation from the packaging instruction, with written authorization by an appropriate person.

i)        The quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or retuned to stock and the quantities of product obtained to permit an adequate reconciliation.

Standard operating procedure (SOPs)
Standard operating procedure and associated records of actions taken or, where appropriate, conclusions reached should be available for:
a)      equipment assembly and validation.
b)      Analytical apparatus and calibration.
c)      Maintenance, cleaning and sanitization.
d)     Personnel matter including qualification, training, clothing and hygiene:
e)      Environment monitoring
f)       Pest control
g)      Complaints
h)      Recalls
i)        Returns

·         There should be standard operating procedures and records for the receipt of each delivery of starting material and primary and printed packaging material.

The records of the receipts should include.
(a)                The name of the material on the delivery note and the containers
(b)               The “in-house” name and/or code of material it different from (a)
(c)                The date of receipt
(d)               The supplier’s name and, if possible, manufacturer’s name
(e)                The manufacturer’s batch or reference number
(f)                The total quantity and number of containers received.
(g)               The batch number assigned after receipt
(h)               Any relevant comment (e.g. state of the containers)

·         There should be standard operating procedures for the internal labeling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate.

·         Standard operating procedures should be available for each instrument and place of equipment (e.g. use, calibration, cleaning, maintenance) and placed in close proximity to the equipment

The Other Various Analysis Records
These records includes:
·         Written release and rejection record should be available for materials and products, and in particular for the release for sale of the finished product by an authorized person

·         Records should be maintained of the distribution of each batch of a product in order, e.g. to facilitate the recall of the batch if necessary.

·         Records should be kept for major and critical equipment, as appropriate, of any validations, calibrations, maintenance, cleaning or repair operations, including dates and the identity of the people who carried these operations out.

·         The use of major and critical equipment and the areas where products have been processed should be appropriately recorded in chronological order.

·         There should be written procedures assigning responsibility for cleaning and sanitation and describing in sufficient detail the cleaning schedules, methods, equipment and materials to be used and facilities and equipment to be cleaned, such written procedures should be followed .(WHO, VOl 2).

These include the records which are come under WHO GMP as well as include the other records that are:
Device master record
Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved. The DMR for each type of device shall include, or refer to the location of, the following information:
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and processes used; and
(e) Installation, maintenance, and servicing procedures and methods.

Device history record.
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used.

Quality system record.
Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part Each manufacturer shall ensure that the QSR is prepared and approved.

Complaint files
(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:
(1) All complaints are processed in a uniform and timely manner;
(2) Oral complaints are documented upon receipt; and
(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA.

(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

(d) Any complaint that represents an event which must be reported to FDA shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified.

(e) records of investigation under this paragraph shall include a determination of:
(1) Whether the device failed to meet specifications;

(2) Whether the device was being used for treatment or diagnosis; and

(3) The relationship, if any, of the device to the reported incident or adverse event.

(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.

(f) When the manufacturer’s formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of M investigation shall be reasonably accessible to the manufacturing establishment.

(g) If a manufacturer’s formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either:

(1) A location in the United States where the manufacturer’s records are regularly kept; or

(2) The location of the initial distributor. ((


Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.

1. Specificationsdescribe 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.

Manufacturing Formulae, Processing and Packaging Instructionsstate all the starting materials used and lay down all processing and packaging operations.

Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, equipment operations.

Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent for the quality of the final product.

2. Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorization dossiers.

3. Documents should be approved, signed and dated by appropriate and authorized persons.

4. Documents should have unambiguous contents; title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.

5. Documents should be regularly reviewed and kept up-to-date. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents.

6. Documents should not be hand-written; although, where documents require the entry of data, these entries may be made in clear, legible, indelible handwriting. Sufficient space should be provided for such entries.

7. Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.

8. The records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable. They should be retained for at least one year after the expiry date of the finished product.

9. Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data processing methods, only authorized persons should be able to enter or modify data in the computer and there should be a record of changes and deletions; access should be restricted by passwords or other means and the result of entry of critical data should be independently checked. Batch records electronically stored should be protected by back-up transfer on magnetic tape, microfilm, paper or other means. It is particularly important that the data are readily available throughout the period of retention.



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